Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
Hoya Lens UK LtdIndustrial Estate Wrexham

Cross Lanes
LL13 9UA.

United Kingdom







01/05/20095766
  • Spectacle Lenses :
  • ,
  • Prescribed Spectacles :
  • ,
  • Prescription spectacle lens non-customized :
  • ,
  • Prescription spectacle lens non-customized :
HOYA Medical Singapore Pte Ltd455A Jalan Ahmad Ibrahim

Singapore
639939

Singapore

Hoya Lens UK LtdUK Responsible PersonIndustrial Estate Wrexham

Cross Lanes
LL13 9UA.
UK Responsible Person
United Kingdom
04/15/202113428
  • Intraocular lens calculation software :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
Hoya Technosurgical CorporationYKB Bldg. 4-28-4 Yotsuya
Shinjuku-ku
Tokyo
160-0004

Japan

Hoya Lens UK LtdUK Responsible PersonIndustrial Estate Wrexham

Cross Lanes
LL13 9UA.
UK Responsible Person
United Kingdom
08/17/202225586
  • Surgical binoculars reusable :
Hoyotek Biomedical Co. Ltd.Floor 4 Zone C Workshop No. 1 China Civil Aviation Science and Technology Industrialization Base No. 225 Jinger Road Tianjin Airport Economic Zone

Tianjin
300308

China

QAdvis UK LtdUK Responsible Person55-66 Frederick Street

Edinburgh EH2 1LS
EH2 1LS
UK Responsible Person
Scotland United Kingdom
04/29/202223248
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM/neutralizing antibody IVD kit rapid ICT clinical :
HPF S.R.L.Via A. Marcuzzi 2/5

Fagagna (UD)
33034

Italy

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/15/202118314
  • Fluted surgical drill bit reusable :
  • ,
  • Acetabular orthopaedic reamer :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Acetabulum prosthesis trial prefabricated reusable :
  • ,
  • Bone-resection orthopaedic reamer single-use :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic chisel :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic chisel blade :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Chisel/osteotome blade handle :
  • ,
  • Orthopaedic osteotome blade reusable :
  • ,
  • Surgical instrument/implant rack :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Femoral head prosthesis trial :
  • ,
  • Orthopaedic instrument extractor :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Orthopaedic implant/instrument assembling device :
HQ Dental Laboratory Ltd.349 Tong Road

Leeds
West Yorkshire LS12 4QG

United Kingdom







05/13/20144618
  • Bar dental precision attachment :
  • ,
  • Bite registration rim :
  • ,
  • Ceramic dental inlay :
  • ,
  • Bonded dental bridge :
  • ,
  • Complete lower denture :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made organ/bone anatomy model :
  • ,
  • Custom-made organ/bone anatomy model/surgical guide kit :
  • ,
  • Dental base plate :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental cusp permanent :
  • ,
  • Dental cusp temporary :
  • ,
  • Dental guided surgery reference plate :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Dental veneer professional :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Gold dental inlay :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Mouthguard single-use :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic bracket metal :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic clasp metal custom-made :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic spring :
  • ,
  • Palate prosthesis :
  • ,
  • Partial denture :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Teeth whitening kit :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Vacuum mouldable splint :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
HR Pharmaceuticals Inc3630 Concord Road

York
Pennsylvania 17402

United States

Nissha Medical Technologies LtdUK Responsible PersonTorbay Business Park Woodview Road

Paignton
Devon TQ4 7HP
UK Responsible Person
United Kingdom
08/10/202116629
  • Skin topical coupling gel :
  • ,
  • Topical coupling gel sterile :
HRM INTERNATIONAL LTD. T/a Specscart.10 Union Street

Bury
BL9 0NY

England United Kingdom

specscart@gmail.com






10/18/20176249
  • Spectacle Frames :
  • ,
  • Ready-Made Spectacles (Non-Prescribed) :
  • ,
  • Spectacle Lenses :
HS DOMS GmbHLANGENSCHADER STRASSE 67

D-07318 SAALFELD
EU

Germany

HAAG STREIT UK LTDUK Responsible PersonUnit A Cartel Business Estate
EDINBURGH WAY
HARLOW
ESSEX CM20 2TT
UK Responsible Person
United Kingdom
11/06/202118858
  • Ophthalmic instrument table line-powered :
HSD S.r.l.Strada Acquasalata 11

Serravalle
Serravalle 47899

San Marino

STERILINE LIMITEDUK Responsible Person20-22 Wenlock Road

London
N1 7GU
UK Responsible Person
England United Kingdom
07/18/202219137
  • Physical therapy ultrasound system :
  • ,
  • Deep-tissue electromagnetic stimulation system home-use :
  • ,
  • Analgesic transcutaneous electrical nerve stimulation system :
HSDU George Eliot Hospital NHS TrustCollege Street

Nuneaton
CV10 7DJ

United Kingdom







04/11/20227156
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Ophthalmic surgical procedure kit non-medicated reusable :
  • ,
  • Nephroscopic surgical procedure kit non-medicated reusable :
  • ,
  • Cardiothoracic surgical procedure kit non-medicated reusable :
  • ,
  • Arthroscopic surgical procedure kit non-medicated reusable :
  • ,
  • Obstetrical/gynaecological surgical procedure kit non-medicated reusable :
  • ,
  • General surgical procedure kit non-medicated reusable :
  • ,
  • Urological surgical procedure kit non-medicated reusable :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • ENT surgical procedure kit non-medicated reusable :
HSDU Royal Infirmary EdinburghLittle France Old Dalkeith Road

Edinburgh
EH16 4SU

United Kingdom







04/05/20222779
  • Obstetrical/gynaecological surgical procedure kit non-medicated reusable :
  • ,
  • Cardiothoracic surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • ENT surgical procedure kit non-medicated reusable :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • Arthroscopic surgical procedure kit non-medicated reusable :
  • ,
  • General surgical procedure kit non-medicated reusable :
  • ,
  • Nephroscopic surgical procedure kit non-medicated reusable :
  • ,
  • Neurosurgical procedure kit non-medicated reusable :
  • ,
  • Ophthalmic surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Urological surgical procedure kit non-medicated reusable :
Hsiner Co. Ltd.No. 312 Jhongshan Rd. Shengang Dist.

Taichung City
429

Taiwan

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202217459
  • Inspiratory/expiratory limb respiratory tubing reusable :
  • ,
  • CPAP/BPAP face mask single-use :
  • ,
  • Straight/elbow breathing circuit connector single-use :
  • ,
  • Anaesthesia face mask single-use :
  • ,
  • Microbial medical gas filter single-use :
  • ,
  • CPAP/BPAP face mask reusable :
  • ,
  • CPAP/BPAP nasal mask reusable :
  • ,
  • Anaesthesia mask strap reusable :
  • ,
  • Nasal oxygen cannula basic :
  • ,
  • CPAP/BPAP face mask reusable :
  • ,
  • CPAP/BPAP nasal mask reusable :
HT Co. Ltd.10 Sinjeong-Ro 159beon-gil Giheung-Gu

Yongin-si
Gyeonggi-Do 16945

South Korea

UKCA Experts Ltd.UK Responsible PersonDept 302 43 Owston Road Carcroft

Doncaster
DN6 8DA
UK Responsible Person
England United Kingdom
info@ukca-experts.com
10/06/202226389
  • Orthodontic bracket ceramic :
HTK Enterprises Inc. dba InterX Technologies870 N. Dorothy Drive Suite 708

Richardson
Texas 75081

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/07/202118880
  • Transcutaneous electrical stimulation electrode reusable :
  • ,
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
HTL-Strefa S.A.ul. Adamówek 7

Ozorków
95-035

Poland

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202217457
  • Manual blood lancing device reusable :
  • ,
  • Autoinjector needle :
  • ,
  • Blood lancet single-use :
HTZ LtdUnit 4 Imberhorne Lane

East Grinstead
Sussex RH19 1XP

England United Kingdom







02/19/202212232
  • Laboratory instrument/analyser application software IVD :
Hu-Friedy Mfg. Co. LLC3232 N Rockwell St.

Chicago
IL 606018

United States

STERIS Solutions LimitedUK Responsible PersonChancery House Rayns Way Watermead Business Park
Syston
Leicester
Leicestershire LE7 1PF
UK Responsible Person
England United Kingdom
10/14/202226484
  • Scalpel handle reusable :
  • ,
  • Medical equipment drape single-use :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Sterilization packaging single-use :
  • ,
  • Gauze packer :
  • ,
  • Rubber dam clamp :
  • ,
  • Dental rongeur :
  • ,
  • Mouth gag non-adjustable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Endodontic filling material condenser :
  • ,
  • Manual bone mill :
  • ,
  • Dental mirror reusable :
  • ,
  • Orthodontic metal band pusher :
  • ,
  • Dental articulation paper forceps :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental collar/crown scissors :
  • ,
  • Periodontal probe reusable :
  • ,
  • Rubber dam frame :
  • ,
  • Margin finishing dental file/rasp reusable :
  • ,
  • Manual endodontic file/rasp reusable :
  • ,
  • Periodontal hoe :
  • ,
  • General-purpose calliper metallic :
  • ,
  • Surgical mallet :
  • ,
  • Surgical tamp reusable :
  • ,
  • Wire cutter :
  • ,
  • Dental matrix band retainer :
  • ,
  • Orthodontic pliers :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Rubber dam punch :
  • ,
  • Chemical/physical sterilization process indicator :
  • ,
  • Periodontal file/rasp manual :
  • ,
  • Tooth extraction forceps :
  • ,
  • Dental amalgam carrier :
  • ,
  • Dental restoration carver amalgam reusable :
  • ,
  • Dental wax carver :
  • ,
  • Dental excavator reusable :
  • ,
  • Dental explorer :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Dental amalgam well :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Dental irrigation/aspiration syringe :
  • ,
  • Orthodontic ligature director :
  • ,
  • Manual endodontic filling material spreader :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Dental spatula reusable :
  • ,
  • Instrument storage cabinet :
  • ,
  • Periodontal knife :
  • ,
  • Periodontal curette :
  • ,
  • Dental restoration carver resin :
  • ,
  • Endodontic plugger :
  • ,
  • Syndesmotome :
  • ,
  • Bone graft syringe single-use :
  • ,
  • Interproximal dental gauge reusable :
  • ,
  • Dental cheek retractor professional reusable :
  • ,
  • Dental cheek retractor professional reusable :
  • ,
  • Dental osteotome :
  • ,
  • Dappen dish reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Periotome reusable :
  • ,
  • Periotome reusable :
  • ,
  • Paranasal sinus curette :
  • ,
  • Dental implant system :
  • ,
  • Dental implant system :
  • ,
  • Sterilization container filter :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Surgical instrument containment holder reusable :
  • ,
  • Dental material application tool reusable :
  • ,
  • Manual dental burnisher reusable :
  • ,
  • Manual dental burnisher reusable :
  • ,
  • Gauze packer :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Dental spatula reusable :
  • ,
  • Periodontal curette :
  • ,
  • Dental restoration carver resin :
  • ,
  • Endodontic plugger :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Margin finishing dental file/rasp reusable :
  • ,
  • Surgical mallet :
  • ,
  • Periodontal file/rasp manual :
  • ,
  • Dental excavator reusable :
  • ,
  • Manual endodontic filling material spreader :
  • ,
  • Periodontal knife :
Huachenyang (Shenzhen) Technology Co. Ltd.8F & 11F Building 4 128# Shangnan East Rd
Huangpu Community Xinqiao St Bao'an
Shenzhen
Guangdong 518125

China

SHARE INFO LTDUK Responsible Person3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS
UK Responsible Person
England United Kingdom
03/31/202223815
  • General specimen collection kit IVD clinical :
  • ,
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • General-purpose absorbent tip applicator/swab single-use :
  • ,
  • General-purpose absorbent tip applicator/swab single-use :
HuaiYin Medical Instruments Co. Ltd.No.8 MingYuan West Road

Huaian City Jiangsu
223000

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
12/22/202120862
  • Polyester suture bioabsorbable multifilament non-antimicrobial :
  • ,
  • Polyester suture bioabsorbable monofilament non-antimicrobial :
  • ,
  • Metallic suture multifilament :
  • ,
  • Nylon suture non-bioabsorbable multifilament :
  • ,
  • Silk suture :
  • ,
  • Polyester suture non-bioabsorbable multifilament :
  • ,
  • Polyolefin suture monofilament :
  • ,
  • Surgical retractor/retraction system blade single-use : Surgical retractor/retraction system blade single-use Conformity Assessment Certificate Expired
  • ,
  • Scalpel single-use : Scalpel single-use Conformity Assessment Certificate Expired
Huanghua Promisee Dental Co LtdMould Industry Garden Empolder Section

Hebei
Huanghua 061100

China

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202215388
  • Dental delivery system irrigation handpiece tip :
  • ,
  • Face splash shield single-use :
  • ,
  • Custom-made dental composite resin kit :
  • ,
  • Dental material application tool single-use :
  • ,
  • Denture cleaning container :
  • ,
  • Dental cheek retractor professional reusable :
  • ,
  • Dental suction system cannula single-use :
  • ,
  • Dental material mixing surface reusable :
  • ,
  • Dental matrix band kit :
  • ,
  • Periodontal medication dispenser :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Dental wedge single-use :
  • ,
  • Dental spatula reusable :
  • ,
  • Dressing dispenser :
  • ,
  • Dental impression tray reusable :
  • ,
  • Orthodontic positioner seater :
  • ,
  • Orthodontic appliance remover :
Huawei Device Co. Ltd.No.2 of Xincheng Road Songshan Lake Zone

Dongguan
Guangdong 523808

China

HUAWEI TECHNOLOGIES (UK) CO. LTD.UK Responsible Person300 South Oak Way

Reading
RG2 6AD
UK Responsible Person
England United Kingdom
09/09/202225858
  • Cardiac electrophysiology application software :
  • ,
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
Huayuan Medical Technology(Shangqiu) Co. Ltd.In The North Yard 1km West of The Intersection of Zhuangzhou Avenue and Pingyuan Road Liangyuan District

Shangqiu City
Henan Province 476000

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
04/27/202113975
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
HuBDIC Co. Ltd301 191-1 Anyang-dong Manan-gu

Anyang-si
Gyeonggi-do 14084

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
02/17/202223066
  • Infrared patient thermometer skin :
  • ,
  • Nasal aspirator manual :
Hubei Kangning Protective Products Co. LtdSpecial No.1 Xuefu Road Xiantao

Hubei Province
433000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
09/23/202117747
  • Surgical gown single-use :
  • ,
  • Surgical/medical face mask single-use :
Hubei MEIBAO Biotechnology Co. LtdNo.5 Hongfu Road Shayang Economic Development Zone Jingmen City

Hubei Province
448200

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
05/16/202224650
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
Hubei Qianjiang Kingphar Medical Material CO. LtdYuanguang Road

Qianjiang
433100

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202222093
  • General-purpose surgical sponge :
  • ,
  • Non-woven gauze pad :
  • ,
  • Woven gauze pad :
  • ,
  • Cotton wool ball :
  • ,
  • Dry medical towel/wipe single-use :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Skin-cleaning wipe non-sterile :
  • ,
  • Woven gauze pad :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • First aid absorbent pad/bandage :
  • ,
  • Isolation gown single-use :
Hubei Wanli Protective Products Co. Ltd.Yuanshi Ganhe Xiantao

Hubei Province
433000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
03/16/202112529
  • Surgical gown single-use :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Surgical cap single-use :
  • ,
  • Isolation gown single-use :
  • ,
  • Surgical coverall :
Hubei Weikang Protective Products Co. LtdGongqing Chuangye Industrial Zone Yewang Rd. Xiantao

Hubei Province
433000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
09/07/202117317
  • Surgical/medical face mask single-use :
Hubei Xinxin Non-woven Co. LtdTaizihu Industrial Park Pengchang Town

Xiantao
Hubei 433018

China

SHARE INFO LTDUK Responsible Person3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS
UK Responsible Person
England United Kingdom
11/05/202119703
  • Isolation gown single-use :
  • ,
  • Surgical/medical face mask single-use :
Hubert De Backer n.v.Laagstraat 59

Temse
Oost-Vlaanderen 9140

Belgium

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202219576
  • ENFit oral/enteral syringe reusable :
  • ,
  • ENFit oral/enteral syringe reusable :
  • ,
  • Vial/bottle adaptor non-hermetic :
Hucknall Dental Laboratory Ltd41 Hayden Lane Hucknall

Nottingham
Nottinghamshire NG15 8BS

United Kingdom







08/25/99436
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold artificial teeth :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture reliner hard :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Bar dental precision attachment :
  • ,
  • Bonded dental bridge :
  • ,
  • Denture reliner elastic long-term :
  • ,
  • Partial denture :
  • ,
  • Dental veneer professional :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Root canal post custom-made :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Custom-made dental anatomy model :
  • ,
  • Dental anchor :
  • ,
  • Dental appliance/prosthesis connector :
  • ,
  • Dental base plate :
  • ,
  • Dental casting noble alloy :
  • ,
  • Dental implant suprastructure temporary custom-made :
  • ,
  • Resin dental inlay :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental Appliances/Prostheses :
Hugh Steeper LtdUnit 3 Stourton Link Intermezzo Drive

LEEDS
West Yorkshire LS10 1DF

United Kingdom







09/17/20156617
  • Wrist/hand orthosis :
  • ,
  • Orthotic insole custom-made :
  • ,
  • Orthotic shoe custom-made :
  • ,
  • Orthotic helmet :
  • ,
  • Orthotic shoe adapted :
  • ,
  • Hip/knee/ankle/foot orthosis :
  • ,
  • Lumbar spine orthosis :
  • ,
  • Cervical spine collar reusable :
  • ,
  • Thoracic cage orthosis :
  • ,
  • Body-powered elbow prosthesis locking :
  • ,
  • Body-powered hand prosthesis :
  • ,
  • Electrical elbow prosthesis :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • External limb prosthesis finishing component non-customized :
  • ,
  • Myoelectric hand prosthesis :
  • ,
  • Passive hand prosthesis :
  • ,
  • Passive wrist prosthesis :
  • ,
  • Split-hook/specialized-tool hand prosthesis :
Hughes and Farrugia4 Canal Street Droylsden

Manchester
Lancashire M43 7UN

United Kingdom







09/27/20104743
  • Dental Appliances/Prostheses :
Hughes Dental Laboratory LtdSykes Grove

Harrogate
HG1 2DB

United Kingdom







04/09/20225723
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Gold dental inlay :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
Huidu Shanghai Medical Sciences Ltd.Building 11 1698 Wangyuan Road Fengxian

Shanghai
201499

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
04/20/202224297
  • Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
Huizhou Carefit Medical Electronic Co. Ltd.4 Floor-A Jianmin Pharmaceutical Building Taoqian New Village
Sandong Town Huicheng District
Huizhou City Guangdong
516007

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/21/202113649
  • Electrocardiographic lead set reusable :
  • ,
  • Electrocardiographic electrode reusable :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Electrocardiographic electrode reusable :
Huizhou Foryou Medical Devices Co. Ltd.North Shangxia Rd. Dongjiang Hi-tech Industry Park

Huizhou
516005

China

KINGSMEAD SERVICE LIMITEDUK Responsible Person19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
07/26/202116237
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
  • ,
  • Wound hydrogel dressing non-antimicrobial :
  • ,
  • Wound hydrogel dressing non-antimicrobial :
  • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
  • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
  • ,
  • Wound-nonadherent dressing permeable non-antimicrobial :
  • ,
  • Plant polysaccharide haemostatic agent non-bioabsorbable non-antimicrobial :
  • ,
  • Intranasal splint non-biodegradable :
  • ,
  • Dressing-fixation skin adhesive tape silicone :
  • ,
  • Scar management dressing reusable :
  • ,
  • Ear wick non-biodegradable :
  • ,
  • Ophthalmic sponge :
Huizhou Jinghao Medical Techology Co. Ltd.Floor 6 Huicheng Industry Building No.9 Huifeng Dong'er Road Zhongkai High-tech Zone Huizhou City Guangdong Province China

Huizhou
Guangdong 516000

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202214359
  • Air-conduction hearing aid behind-the-ear :
  • ,
  • Air-conduction hearing aid in-the-ear :
Huizhou Kaiyi Technology Co. Ltd7# Xingqian Road 2 Fuxing Industrial Zone Yuanzhou Town

Huizhou
Guangdong 516123

China

Umedwings UK LTDUK Responsible Person291 Brighton Road

South Croydon
CR2 6EQ
UK Responsible Person
England United Kingdom
10/27/202226651
  • Incentive spirometer :
  • ,
  • Nasopharyngeal medicine administration kit atomizer :
  • ,
  • Medicine chamber spacer reusable :
Huizhou Videya Technology Co. Ltd.Factory of Songshan Villagers Group Baishi Village
Qiuchang Street Office Huiyang District
Huizhou City Guangdong
516221

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
11/22/202227045
  • Rotary/reciprocating endodontic file/rasp single-use :
Hull University Teaching Hospital3-5 Harrow Street

Hull
North Humberside HU3 4LB

England United Kingdom







02/07/20132355
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
  • ,
  • Surgical Instrument Accessories :
  • ,
  • Dental Instruments (Re-Usable & Non-Powered) :
  • ,
  • Handheld Dental Mirrors And Accessories :
  • ,
  • Orthodontic Materials (Extra-Oral/Intra-Oral Transient And Short-Term Use) :
  • ,
  • Electrodes/Transducers And Accessories :
  • ,
  • Endoscopes/Endoscopic Instruments And Accessories :
  • ,
  • Laryngoscopes/Otoscopes And Accessories :
  • ,
  • Resuscitation Devices (Non-Active) And Accessories :
  • ,
  • Sterilisation Packaging :
  • ,
  • Accessories For Implantable Devices (Non-Invasive) :
  • ,
  • Cotton Wool/Gauze/Non Woven/PVA(Ribbons/Swab/Buds) :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Vaginal Speculums :
  • ,
  • Nasal Speculum :
  • ,
  • Urinary Catheters (Transient Use) And Accessories :
  • ,
  • Ophthalmic Surgical Procedure Packs :
  • ,
  • Orthodontic Procedure Packs :
  • ,
  • Ward Dressing Packs :
  • ,
  • Theatre Dressing Packs :
  • ,
  • Endoscopes/Endoscopic Instruments And Accessories :
HUMA THERAPEUTICS LIMITED13th floor Millbank Tower 21-24 Millbank
Westminster
London
London SW1P 4QP

England United Kingdom







04/07/20224016
  • Self-care monitoring/reporting software :
  • ,
  • Self-care monitoring/reporting software :
Human Care HC ABÅrstaängsvägen 21B

Stockholm
117 43

Sweden

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
05/13/202224631
  • Basic electric hospital bed :
  • ,
  • Bedrail :
  • ,
  • Bed extension :
  • ,
  • Bed head/footboard :
  • ,
  • Breathing circuit tube holder :
  • ,
  • Intravenous pole :
  • ,
  • Frame/rail/pole device holder :
  • ,
  • Patient lifting pole :
HUMAN Gesellschaft für Biochemica und Diagnostica mbHMax-Planck-Ring 21

Wiesbaden
65205

Germany

Cambridge Life Sciences LtdUK Responsible Person14 St. Thomas' Place

Ely
Cambridgeshire CB7 4EX
UK Responsible Person
England United Kingdom
12/22/202121401
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Blood glucose/blood pressure monitoring system point-of-care :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD kit multiplex :
  • ,
  • Complement component C1q IVD kit enzyme immunoassay (EIA) :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Fibrinogen assay (factor I) IVD kit clotting :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Ion-selective analyser IVD semi-automated :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Microplate reader IVD semi-automated :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory semi-automated :
  • ,
  • Multiple lipid analyte IVD control :
  • ,
  • Multiple lipid analyte IVD reagent :
  • ,
  • Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Non-specific circulating immune complex (CIC) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Nucleosomal antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Phosphatidylserine antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Phospholipid antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Prothrombin antibody (anti-prothrombin) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple liver disease-associated antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Plasmodium falciparum antigen IVD kit rapid ICT clinical :
  • ,
  • Salmonella typhi total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroglobulin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid peroxidase (TPO) IVD antibody :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total complement activity (CH50) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Treponema pallidum reagin antibody IVD kit agglutination :
  • ,
  • Treponema pallidum total antibody IVD kit rapid ICT clinical :
  • ,
  • Trypanosoma cruzi total antibody IVD kit rapid ICT clinical :
  • ,
  • Uric acid IVD control :
  • ,
  • Urine analyser IVD laboratory semi-automated :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory :
  • ,
  • Uric acid IVD reagent :
  • ,
  • Total cholesterol lipid IVD reagent :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD reagent :
  • ,
  • Creatinine IVD reagent :
  • ,
  • Urea IVD reagent :
  • ,
  • Albumin IVD reagent :
  • ,
  • Total aspartate aminotransferase (AST) IVD reagent :
  • ,
  • Alanine aminotransferase (ALT) IVD reagent :
  • ,
  • Multiple clinical chemistry enzyme IVD control :
  • ,
  • Activated partial thromboplastin time (APTT) IVD kit clotting :
  • ,
  • Thrombin time (TT) IVD kit clotting :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis C virus total antibody IVD kit enzyme immunoassay (EIA) :
Human med GmbH9
Wilhelm-Hennemann-Str. Schwerin
Schwerin
Mecklenburg-Vorpommern 19061

Germany

Tom Ladds Consulting LimitedUK Responsible PersonMEADOW COTTAGE HIGHER LANE KERRIDGE

Macclesfield
Cheshire SK10 5AR
UK Responsible Person
United Kingdom
04/15/202218299
  • Liposuction system :
  • ,
  • Liposuction system cannula single-use :
  • ,
  • Stromal vascular fraction recovery set :
  • ,
  • Liposuction system cannula reusable :
  • ,
  • Autologous adipose tissue collection/washing set :
  • ,
  • Autologous adipose tissue collection/injection set :
Human Protection BVDroogdokkeneiland 15

Tilburg
Noord Brabant 5026SP

Netherlands

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202223034
  • Finger protector single-use :
Human Xtensions Ltd.Grand Netter Building Meir Ariel St. 4

Netanya
4250574

Israel

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
06/14/202224842
  • Endoscopic electromechanical surgical system :
  • ,
  • Endoscopic electrosurgical electrode monopolar single-use :
  • ,
  • Endoscopic electromechanical surgical system :
  • ,
  • Laparoscopic surgical procedure kit non-medicated single-use :
Humankind Ventures LtdBasepoint Business Centre Beaufort Park

Chepstow
NP16 5UH

Wales United Kingdom







01/25/202111752
  • Phlebotomy kit :
  • ,
  • Blood lancet single-use :
  • ,
  • Blood lancet single-use :
  • ,
  • Medical equipment clinical data interfacing software :
HumanOptics Holding AGSpardorfer Str. 150

Erlangen
91054

Germany

Kestrel Ophthalmics LtdUK Responsible PersonUnit 9 Cabot Business Village Holyrood Close

Poole
Dorset BH17 7BA
UK Responsible Person
United Kingdom
03/03/202213152
  • Posterior-chamber intraocular lens pseudophakic :
HumanTech Spine GmbHGewerbestrasse 5

Steinenbronn
71144

Germany

Osteon Medical LtdUK Responsible Person133 Tame Road Birmingham

Birmingham
B67DG
UK Responsible Person
England United Kingdom
03/19/202222714
  • Vertebral body prosthesis :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Bone-screw internal spinal fixation system non-sterile :
Humasis Co. Ltd.Rm.114 502 504 604 604-1 B03-01 B03-02 88 Jeonpa-ro Dongan-gu

Anyang-si
Gyeonggi-do 14042

South Korea

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
06/22/202115215
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
Humeca BVOostermaat 5

Borne
7623 CS

Netherlands

Eurosurgical LtdUK Responsible PersonMerrow Business Park
Guildford
Guildford
Surrey GU4 7WA
UK Responsible Person
England United Kingdom
05/24/202114908
  • Dermatome blade single-use :
  • ,
  • Skin graft carrier :
  • ,
  • Woven gauze pad :
Hunan Accurate Bio-Medical Technology Co. Ltd6th Floor Biyang Industrial Zone Lijiacun Road Xueshi Street of Yuelu District

Changsha
Hunan 410208

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202216345
  • Pulse oximeter :
  • ,
  • Pulse oximeter :
  • ,
  • Foetal Doppler system :
Hunan Beyond Medical Technology Co. Ltd.Beyond Zone Lijiacun Rd Xueshi Street
Yuelu District
Changsha Hunan
410208

China
+86-731-82560162
meccy.cheng@csbeyond.com
Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/26/202113778
  • Bedside syringe pump :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Home CPAP unit :
  • ,
  • Home BPAP unit :
  • ,
  • CPAP/BPAP nasal mask reusable :
  • ,
  • CPAP/BPAP face mask reusable :
Hunan Beyond Medical Technology Co. LtdBeyond Zone Lijiacun Rd Xueshi Street Yuelu District

Changsha
410208

China

Umedwings UK LTDUK Responsible Person291 Brighton Road

South Croydon
CR2 6EQ
UK Responsible Person
England United Kingdom
07/12/202225209
  • Bedside syringe pump :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Home CPAP unit :
  • ,
  • Home BPAP unit :
  • ,
  • Home CPAP unit :
  • ,
  • Home BPAP unit :
  • ,
  • CPAP/BPAP nasal mask reusable :
  • ,
  • CPAP/BPAP face mask reusable :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Bedside syringe pump :
Hunan Eexilnherent Pharmaceutical Co. Ltd.No.6 North of Pingtou Road Liuyang Hi-tech Industrial Development Zone

Hunan Province
410323

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
03/01/202223322
  • Surgical/medical face mask single-use :
Hunan Runmei Gene Technology Co. Ltd.Room 401-1 Building 3 Shanhe Medical and Health Industrial Park No. 1048 Zhongqing Road Shaping Street Kaifu District

Changsha
Hunan 410153

China

KINGSMEAD SERVICE LIMITEDUK Responsible Person19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
06/15/202224943
  • Oral/upper respiratory tract specimen collection kit IVD clinical :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
Hunan Triplex Precision Medical Devices Co. Ltd.Room 612 & 613 Building No.5~8 SUNVO Health & Medicine Industrial Park No.1048 Zhongqing Road
Kaifu District
Changsha Hunan
410000

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
03/12/202212581
  • Surgical/medical face mask single-use :
Hunan Vathin Medical Instrument Co. Ltd.1/F Building 12 Innovation and Entrepreneurship Service Center No 9 Chuanqi West Road Jiuhua Economic Development Zone

Xiangtan
Hunan 411100

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202220067
  • Flexible video bronchoscope single-use :
  • ,
  • Endoscopic video image processing unit :
  • ,
  • Endoscopic video image display unit :
Hunt Developments (UK) LtdUnit 15-18 Holmbush Industrial Estate

Midhurst
West Sussex GU29 9HX

United Kingdom







04/05/20222607
  • Sampling And Cell Collection Devices (Patient Contact - Not IVDDs) :
  • ,
  • Oral/upper respiratory tract specimen collection swab :
Hunter Scientific LtdUnit 1 Priors Hall Widdington

Saffron Walden
Essex CB11 3SB

United Kingdom







08/29/20199007
  • Urine test strip colour chart IVD :
  • ,
  • User-induced pipette :
Hunter Urology LtdUnit 1 Skyways Business Park Exeter Airport Industrial Estate

Exeter
Devon EX5 2UL

United Kingdom







04/14/202210161
  • Intermittent urethral catheterization kit non-sterile :
Huntingdon Dental Laboratory LimitedUnit 28 Stephenson Road

St. Ives
Cambridgeshire PE27 3WJ

United Kingdom







04/07/20224635
  • Dental Appliances/Prostheses :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made mouthguard :
  • ,
  • Complete lower denture :
  • ,
  • Partial denture :
Hurev Co LTD104 Gangwon - Techno Park 1642-5 Donghwa

Munmak
26365

South Korea

Unimed Electrodes Supplies LimitedUK Responsible Person10 Farnham Business Centre Dogflud Way

Farnham
GU9 7UP
UK Responsible Person
England United Kingdom
12/03/202120281
  • Electroencephalograph :
Hurricane Medical5315 Lena Road

Bradenton
Florida 34211

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
11/11/202216976
  • Open-surgery dissector :
  • ,
  • Ophthalmic sponge :
  • ,
  • Ophthalmic irrigation/infusion/aspiration cannula non-illuminating single-use :
  • ,
  • Syringe filter clinical :
  • ,
  • Manual intraocular lens injector single-use :
  • ,
  • Hypodermic needle single-use :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • Eye mask :
  • ,
  • Eye mask :
  • ,
  • Skin marking pen single-use :
Hurst Dental Laboratory274 Arundel Street

Portsmouth
Hampshire PO1 1NT

United Kingdom







03/08/20165912
  • Dental Appliances/Prostheses :
Huvitz Co Ltd38 Burim-ro 170 beon-gil
Anyang-si
Gyeonggi-do
14055

South Korea

Mainline Instruments LTDUK Responsible PersonUnit 2 Cyclo Works Lifford Lane
Kings Norton
Birmingham
West Midlands B30 3DY
UK Responsible Person
United Kingdom
10/05/202118038
  • Ophthalmic spectral-domain optical coherence tomography system :
  • ,
  • Ophthalmic tonometer battery-operated :
  • ,
  • Ophthalmic fundus camera :
  • ,
  • Vision testing/training chart :
  • ,
  • Ophthalmic slit lamp examination :
  • ,
  • Phoropter :
  • ,
  • Visual acuity projector :
  • ,
  • Perimeter automatic :
  • ,
  • Automated ophthalmic refractometer :
Huxley Europe LtdFirst Floor 3K Eaton Point Eaton Avenue

Chorley
Lancashire PR7 7NG

England United Kingdom
0161 773 1994
info@huxley-europe.co.uk






04/07/20224115
  • Emollient Bath Additive for Dry Skin Conditions :
  • ,
  • Emollient Wash Gel for Dry Skin Condition :
  • ,
  • Emollient Shower and Bath Gel for Dry Skin Conditions :
Huynh Dental Laboratory11 Brookfield Crescent Headington

Oxford
Oxfordshire OX3 0AZ

England United Kingdom







08/25/99296
  • Dental Appliances/Prostheses :
Hydrofera LLC340 Progress Drive CT

Manchester
Connecticut 06042

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
12/15/202114656
  • Wound-nonadherent dressing permeable antimicrobial :
Hygea Medical Technology Co. Ltd.Floor 6&7 West Area of Building No. 8 No.30 YuHua Road
Shunyi
BEIJING
101318

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
10/21/202226646
  • General cryosurgical system cryogen gas electronic :
  • ,
  • Cryosurgical system temperature probe :
Hygieia Inc.28803 8 Mile Rd.

Livonia
MI 48152

United States

QNET LtdUK Responsible PersonLivingstone House 309 Harrow Road

Wembley
Middlesex HA9 6BD
UK Responsible Person
England United Kingdom
12/29/202121610
  • Home pharmaceutical management support software :
  • ,
  • Glucose monitoring system IVD home-use : Glucose monitoring system IVD home-use Conformity Assessment Certificate Expired
HYGITECH109 bis avenue Charles de Gaulle

NEUILLY SUR SEINE
92200

France

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
07/22/202217734
  • Hot/cold therapy pack reusable :
  • ,
  • Scalpel handle reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Dental mirror reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Periodontal probe reusable :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Syndesmotome :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
  • ,
  • Dental osteotome :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Bone cutting forceps :
  • ,
  • Orthopaedic bone-fragment manipulator single-use non-sterile :
  • ,
  • Orthopaedic implantation hammering attachment :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Dental elevator sinus lift :
  • ,
  • Dental/maxillofacial reciprocating scalpel blade :
  • ,
  • Bone holding forceps :
  • ,
  • Device-irrigation sterile saline solution : Device-irrigation sterile saline solution Conformity Assessment Certificate Expired
  • ,
  • Dental suction system cannula single-use : Dental suction system cannula single-use Conformity Assessment Certificate Expired
  • ,
  • Hot/cold therapy pack single-use : Hot/cold therapy pack single-use Conformity Assessment Certificate Expired
  • ,
  • Surgical/examination garment kit : Surgical/examination garment kit Conformity Assessment Certificate Expired
  • ,
  • Surgical/examination garment kit : Surgical/examination garment kit Conformity Assessment Certificate Expired
  • ,
  • Surgical dressing/drape kit single-use : Surgical dressing/drape kit single-use Conformity Assessment Certificate Expired
  • ,
  • Surgical irrigation/aspiration cannula illuminating single-use : Surgical irrigation/aspiration cannula illuminating single-use Conformity Assessment Certificate Expired
  • ,
  • Surgical irrigation/aspiration cannula illuminating single-use : Surgical irrigation/aspiration cannula illuminating single-use Conformity Assessment Certificate Expired
  • ,
  • Manual non-rotary dental instrument handle : Manual non-rotary dental instrument handle Conformity Assessment Certificate Expired
  • ,
  • Manual non-rotary dental instrument handle : Manual non-rotary dental instrument handle Conformity Assessment Certificate Expired
Hyland Software Canada ULC111 Peter Street Suite 540

Toronto
Ontario M5V 2H1

Canada

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/11/202119105
  • Radiology PACS software :
  • ,
  • Laboratory instrument/analyser application software IVD :
HyperBranch Medical Technology Inc.800-12 Capitola Dr

Durham
27713

United States

Stryker UK LtdUK Responsible PersonStryker House Hambridge Road

Newbury
Berkshire RG14 5AW
UK Responsible Person
England United Kingdom
02/26/202112391
  • Dura mater sealant :
Hyperice Inc525 Technology Drive Suite 100

Irvine
California 92618

United States

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
04/06/202224053
  • Ice bag :
HYPHEN BioMed155 rue d'Eragny

Neuville-sur-Oise
95000

France

OXFORD GENE TECHNOLOGY (OPERATIONS) LTDUK Responsible PersonBegbroke Science Park Begbroke Hill
Woodstock Road
Begbroke
Oxfordshire OX5 1PF
UK Responsible Person
England United Kingdom
11/11/202120068
  • Platelet aggregation study IVD reagent :
  • ,
  • Plasminogen IVD kit chromogenic :
  • ,
  • Tissue plasminogen activator-plasminogen activator inhibitor complex (tPA:PAI) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor Xa inhibitor IVD reagent :
  • ,
  • Heparin anti-Xa IVD kit chromogenic :
  • ,
  • Heparin anti-Xa IVD calibrator :
  • ,
  • Lupus anticoagulant marker IVD kit clotting :
  • ,
  • Protein S IVD kit clotting :
  • ,
  • Activated protein C resistant factor V (factor V Leiden) IVD kit clotting :
  • ,
  • Fibrinogen assay (factor I) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor VIIa IVD calibrator :
  • ,
  • Coagulation factor IX IVD kit chromogenic :
  • ,
  • Heparin anti-Xa IVD control :
  • ,
  • Polyvalent human immunoglobulin antibody IVD antibody :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Protein S IVD kit nephelometry/turbidimetry :
  • ,
  • Direct thrombin inhibitor therapeutic drug monitoring IVD kit chromogenic :
  • ,
  • Direct thrombin inhibitor therapeutic drug monitoring IVD kit clotting :
  • ,
  • Alpha-2-antiplasmin IVD kit chromogenic :
  • ,
  • Protein S IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit nephelometry/turbidimetry :
  • ,
  • Protein C IVD kit enzyme immunoassay (EIA) :
  • ,
  • Antithrombin III (ATIII) IVD kit nephelometry/turbidimetry :
  • ,
  • Coagulation factor VIII IVD kit enzyme immunoassay (EIA) :
  • ,
  • Lupus anticoagulant marker IVD control :
  • ,
  • Multiple therapeutic drugs/drugs of abuse IVD control :
  • ,
  • Plasma protein IVD calibrator :
  • ,
  • Multiple coagulation factor IVD control :
  • ,
  • Calcium chloride coagulation reagent IVD :
  • ,
  • Activated protein C resistance ratio (APCR) IVD control :
  • ,
  • Activated protein C resistant factor V (factor V Leiden) IVD control :
  • ,
  • Protein C IVD kit clotting :
  • ,
  • Protein C IVD kit chromogenic :
  • ,
  • Total immunoglobulin G (IgG total) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Phospholipid antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple therapeutic drugs/drugs of abuse IVD calibrator :
  • ,
  • Activated partial thromboplastin time (APTT) IVD kit clotting :
  • ,
  • Prothrombin time (PT) IVD kit clotting :
  • ,
  • Prothrombin time (PT) IVD calibrator :
  • ,
  • Thrombin time (TT) IVD kit clotting :
  • ,
  • Multiple coagulation factor IVD kit clotting :
  • ,
  • Fibrinogen assay (factor I) IVD kit clotting :
  • ,
  • Coagulation factor II (prothrombin) IVD kit clotting :
  • ,
  • Coagulation factor V IVD kit clotting :
  • ,
  • Coagulation factor VII IVD kit clotting :
  • ,
  • Coagulation factor VIIa IVD kit clotting :
  • ,
  • Coagulation factor VIII IVD kit clotting :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor IX IVD kit clotting :
  • ,
  • Coagulation factor X IVD kit clotting :
  • ,
  • Coagulation factor XI IVD kit clotting :
  • ,
  • Coagulation factor XII IVD kit clotting :
  • ,
  • Coagulation factor XIII IVD kit chromogenic :
  • ,
  • von Willebrand factor: collagen binding activity (vWF:CBA) IVD reagent :
  • ,
  • D-dimer IVD control :
  • ,
  • Protein C IVD reagent :
  • ,
  • Coagulation factor VIII IVD kit chromogenic :
Hywel Dda University Health Board - Bronglais General hospitalCaradog Road

Aberystwyth
Ceredigion SY231ER

Wales United Kingdom







06/08/202215202
  • General surgical procedure kit non-medicated reusable :
Hywel Dda University Health Board - Withybush General HospitalFishguard Road

Haverfordwest
Pembrokeshire SA61 2PZ

Wales United Kingdom







06/08/202215203
  • General surgical procedure kit non-medicated reusable :
H&A Mui Enterprises Inc (Mui Scientific)Unit 34 145 Traders Blvd. E

Mississauga
Ontario L4Z 3L3

Canada

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
11/30/202225907
  • Gastrointestinal motility manometric catheter non-electronic :
  • ,
  • Gastrointestinal motility manometric catheter non-electronic :
  • ,
  • Manometric gastrointestinal motility analysis system :
  • ,
  • Gastrointestinal barostat :
  • ,
  • Endoscopic overtube single-use :
  • ,
  • Rigid nasopharyngoscope :
H&abyz41-16 Cheoinseong-ro Namsa-myeon
Cheoin-gu Yongin-si
Gyeonggi-do
17118

South Korea

MIS Healthcare LtdUK Responsible PersonUnit 26-27 Capitol Way Capitol Park

London
NW9 0EQ
UK Responsible Person
England United Kingdom
03/21/202223709
  • Indirect flat panel x-ray detector :
H&H Medical Corporation328 McLaws Circle

Williamsburg
VA 23185

United States

Safeguard Medical Technologies LtdUK Responsible PersonSafeguard Medical Technologies Ltd
The Old Rectory GBR
LEOMINSTER
Herefordshire HR6 0PW
UK Responsible Person
England United Kingdom
08/11/202218329
  • Pressure bandage non-latex single-use :
  • ,
  • Limb tourniquet manual single-use :
H&H Padiham Ltd40 Hoghton Street

Southport
PR9 0PQ

England United Kingdom







02/27/202212386
  • Prescription spectacles :
H&J Dental Laboratory Ltd17 Stonebridge Green

Newtownards
County Down BT23 7QZ

Northern Ireland United Kingdom







02/28/202223314
  • Orthodontic retainer :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
H&O Equipments NV/SA also trading as 'Clinic6'Rue des Journaliers 1

Ghislenghien
7822

Belgium

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202217636
  • General cryosurgical system cryogen gas mechanical :
  • ,
  • Nitrous oxide gas cartridge :
  • ,
  • Carbon dioxide cartridge non-sterile :
H. + H. Maslanka Chirurgische Instrumente GmbHStockacher Straße 172

Tuttlingen
78532

Germany

Occlutech UK Ltd UK Responsible PersonLynton House 7-12 Tavistock Square
London
London
WC1H9LT
UK Responsible Person
United Kingdom
04/19/202221416
  • Cardiac occluder/interatrial shunt transcatheter introducer :
H.S. HOSPITAL SERVICE S.P.A.via Zosimo 13

Rome
00 178

Italy

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202219709
  • Body aspiration needle single-use :
  • ,
  • Side-notch biopsy gun handpiece/needle :
  • ,
  • Bone marrow biopsy needle single-use :
  • ,
  • Microwave hyperthermia system :
  • ,
  • Radio-frequency ablation system :
  • ,
  • Microwave hyperthermia system applicator intracorporeal :
  • ,
  • Tumour-therapy radio-frequency hyperthermia system applicator intracorporeal :
h/p/cosmos sports and medical gmbhAm Sportplatz 8.
Nußdorf
Traunstein
Oberbayern 83365

Germany

HaB International LtdUK Responsible Person15 Warwick Road

Stratford Upon Avon
Warwickshire CV37 6YW
UK Responsible Person
England United Kingdom
03/22/202219920
  • Parallel bar exerciser non-powered :
  • ,
  • Gait rehabilitation system harness :
  • ,
  • Body/limb elastic exerciser :
h/p/cosmos sports and medical gmbhAm Sportplatz 8

Nußdorf Traunstein
Oberbayern 83365

Germany

HaB International LtdUK Responsible Person15 Warwick Road

Stratford Upon Avon
Warwickshire CV37 6YW
UK Responsible Person
England United Kingdom
03/22/202220023
  • Cardiopulmonary stress exercise treadmill :
I-MED PHARMA Inc.7190 Rue Frederick Banting

Saint-Laurent
Quebec H4S 2A1

Canada
15149731635
Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
11/11/202119128
  • Eye lubricant :
  • ,
  • Tear osmolarity meter :
  • ,
  • Tear osmolarity electrode :
I-MING Sanitary Materials Co LtdNo. 68 Sec.2. Zhongke Erlin Blvd
Meifang Vil
Erlin Township
Changua County 52666

Taiwan

Portsand Ltd T/A Brace OrthopaedicUK Responsible PersonUnit 8 Evans Business Centre Orion Business Park
Orion Way North Shields
North Shields
Tyne & Wear NE29 7SN
UK Responsible Person
England United Kingdom
sales@braceorthopaedic.co.uk
04/19/202221502
  • Shoulder orthosis :
i-Optix96 Drummond Street

London
NW1 2HN

United Kingdom







03/23/20122231
  • Prescription spectacle lens custom-made :
I-RES SAGLP.LE RONCAA 4

MENDRISIO
6850

Switzerland

Fusion Dent LtdUK Responsible PersonMill View House Benstede close
Herne Bay
Kent
Kent CT6 7JP
UK Responsible Person
England United Kingdom
11/24/202227076
  • Basket endosteal dental implant two-piece :
i-SENS Inc.43 Banpo-daero 28-gil Seocho-gu

Seoul
06646

South Korea

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
07/27/202116302
  • Manual blood lancing device reusable :
  • ,
  • Glucose monitoring system IVD home-use :
  • ,
  • Glucose/ketone monitoring system IVD home-use :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD control :
  • ,
  • Fluorescent immunoassay/spectrophotometry analyser IVD point-of-care :
  • ,
  • Glycated haemoglobin (HbA1c) IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Albumin/creatinine ratio (ACR) IVD reagent :
  • ,
  • Albumin/creatinine ratio (ACR) IVD control :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent :
  • ,
  • Metabolic profile clinical chemistry analyser IVD :
I-TEC Independent Technicians Limited81 Chatsworth Drive

Banbury
Oxon OX16 9YJ

United Kingdom







11/25/2003781
  • Spectacle Lenses :
  • ,
  • Spectacle Frames :
I see 3 Limited19 Barnes High street

london
sw13 9lw

England United Kingdom







06/20/202225026
  • Prescription spectacles :
I W Dental Laboratory LtdUnit 7-8 Samara Business Park Cavalier Road Heathfield Industrial Estate

Newton Abbot
Devon TQ12 6TR

United Kingdom







11/23/20094897
  • Bonded dental bridge :
  • ,
  • Bar dental precision attachment :
  • ,
  • Ceramic dental inlay :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Crown surgical drill bit single-use :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental CAD/CAM system laboratory :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Gold dental inlay :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Temporary dental crown/bridge :
I Wear Opticians North Limited133 GODWIN STREET

BRADFORD
WEST YORKSHIRE BD1 3PP

England United Kingdom







04/04/20221718
  • Prescribed Spectacles :
I Wear Opticians73 Main Street Bulwell

Nottingham
Nottinghamshire NG6 8QD

United Kingdom







04/30/20145540
  • Prescribed Spectacles :
I2M Labs16 Bis Fosses Saint-Julien BP200

CAEN
14011

France

Limbco LtdUK Responsible PersonPlough Lane

Hereford
HR4 0EL
UK Responsible Person
England United Kingdom
bgardiner@limbco.uk
07/20/202216434
  • Hyperhidrosis iontophoresis system :
i5 Analytics Limited2 Cedar Grove

London
W5 4AP

England United Kingdom







05/19/202114795
  • Patient general health self-management software :
  • ,
  • Clinical management support software :
Ian Hammerton Private Prosthetics Dental Laboratory34 Station Road

Hinckley
Leicestershire LE10 1AP

United Kingdom







08/11/2000897
  • Dental Appliances/Prostheses :
Ian Taylor Creating Smiles25 Brooks Road

Sutton Coldfield
West Midlands B72 1HP

United Kingdom







04/09/20225898
  • Dental Appliances/Prostheses :
IAS Academy and Labs Ltd22 Wintersells Road
Towergate House
West Byfleet
Surrey KT14 7LF

England United Kingdom







04/08/20225166
  • Dental Appliances/Prostheses :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic teeth positioner preformed :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic wire :
  • ,
  • Orthodontic spring :
  • ,
  • Orthodontic tube :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Dental appliance fabrication material thermoplastic :
IB Medical ABRundelgatan 2

Tranas
573 35

Sweden

TR Equipment UK LtdUK Responsible Personc/o EBS Ltd. Innovation Centre
Gallows Hill
Warwick
Warwickshire CV34 6UW
UK Responsible Person
England United Kingdom
11/15/202120039
  • Lumbosacral spine orthosis hernia support :
  • ,
  • Haemorrhoidal cryotherapy device single-use :
  • ,
  • Haemorrhoidal cryotherapy device reusable :
  • ,
  • Localized cutaneous/musculoskeletal cryotherapy unit :
  • ,
  • Oral mucositis cryotherapy mouthpiece :
IBA Dosimetry GmbHBahnhofstrasse 5

Schwarzenbruck
Bavaria 90592

Germany

Oncology Systems LimitedUK Responsible Person14 Longbow Close

Shrewsbury
Shropshire SY1 3GZ
UK Responsible Person
England United Kingdom
04/20/202217821
  • Radiation electrometer :
  • ,
  • Accelerator system quality assurance device :
  • ,
  • Accelerator system quality assurance device :
  • ,
  • Accelerator system quality assurance device :
  • ,
  • Multi-modality therapeutic radiation phantom anthropomorphic :
  • ,
  • Multi-modality therapeutic radiation phantom anthropomorphic :
  • ,
  • Diagnostic x-ray system quality assurance device :
  • ,
  • Accelerator system quality assurance device :
  • ,
  • Ionization chamber radiation measuring probe :
Iberhospitex S.A.Av. Catalunya 4 Lliçà de Vall

Barcelona
08185

Spain

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
12/16/202114028
  • Drug-eluting coronary artery stent non-bioabsorbable-polymer-coated :
  • ,
  • Thrombectomy rotational catheter :
  • ,
  • Closed-wound drainage kit :
  • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
  • ,
  • Antimicrobial synthetic polymer semi-permeable film dressing adhesive :
  • ,
  • Coronary angioplasty balloon catheter basic : Coronary angioplasty balloon catheter basic Conformity Assessment Certificate Expired
  • ,
  • Vascular guide-catheter single-use : Vascular guide-catheter single-use Conformity Assessment Certificate Expired
  • ,
  • Wearable percutaneous catheter/tube holder : Wearable percutaneous catheter/tube holder Conformity Assessment Certificate Expired
Ibex Medical Analytics Ltd101 Rokach Blvd

Tel Aviv
6153101

Israel

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202221738
  • Clinical management support software IVD :
Ibis Vision Limited60 St. Enoch Square 5th Floor

Glasgow
G1 4AG

Scotland United Kingdom







03/09/202223545
  • Video consultation telemedicine system :
IBL INTERNATIONAL GMBHFLUGHAFENSTRASSE 52A
FLUGHAFENSTRASSE 52A
HAMBURG
22335

Germany

Tecan UK LimitedUK Responsible PersonTheale Court 11-13 High Street

Theale Reading
Berkshire RG7 5AH
UK Responsible Person
England United Kingdom
11/21/202221763
  • 17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Melatonin sulfate IVD kit enzyme immunoassay (EIA) :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD kit radioimmunoassay :
  • ,
  • Acetylcholine receptor antibody IVD kit radioimmunoassay :
  • ,
  • Sperm antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • 5-Hydroxyindoleacetic acid (5HIAA) IVD reagent :
  • ,
  • Cyclic adenosine monophosphate (cAMP) IVD kit radioimmunoassay :
  • ,
  • Haemophilus influenzae culture isolate antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Measles virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tick-borne encephalitis (TBE) virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Interleukin-2 receptor (IL-2r) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Newborn metabolic screen/congenital disorder IVD kit multiplex :
  • ,
  • Total testosterone IVD kit chemiluminescent immunoassay :
  • ,
  • Serotonin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amyloid B component IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free estriol (oestriol) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amylase isoenzyme IVD kit enzyme spectrophotometry :
  • ,
  • Estradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassay :
  • ,
  • Immunoglobulin removal reagent IVD :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Progesterone IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Progesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adiponectin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ferritin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human growth hormone (HGH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Leptin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free cortisol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aldosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Insulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Renin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total triiodothyronine (TT3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Parvovirus B19 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Taenia solium immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Melatonin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Neopterin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total cortisol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple biogenic amine neurotransmitter IVD reagent :
  • ,
  • Melatonin IVD kit radioimmunoassay :
  • ,
  • Hantavirus antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free cortisol IVD kit chemiluminescent immunoassay :
  • ,
  • Dehydroepiandrosterone (DHEA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cyclic guanosine monophosphate (cGMP) IVD kit radioimmunoassay :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Chikungunya virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Chikungunya virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • High mobility group box 1 (HMBG1) protein IVD kit enzyme immunoassay (EIA) :
  • ,
  • Muscle-specific kinase receptor (MuSK) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dehydroepiandrosterone (DHEA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • General specimen container IVD no additive/medium :
  • ,
  • Multiple steroid hormone IVD kit mass spectrometry :
  • ,
  • General specimen container IVD no additive/medium :
IBSA Farmaceutici Italia SrlVia Martiri di Cefalonia 2

Lodi
26900

Italy

Regulis Consulting LimitedUK Responsible PersonWessex House Marlow Road

Bourne End
Buckinghamshire SL8 5SP
UK Responsible Person
England United Kingdom
04/21/202113622
  • Bladder instillation barrier :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
  • ,
  • Dermal tissue reconstructive material microbe-derived : Dermal tissue reconstructive material microbe-derived Conformity Assessment Certificate Expired
  • ,
  • Bladder instillation barrier :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
iCAD Inc.98 Spit Brook Road Suite 100

Nashua NH
03062

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
01/07/202221832
  • Diagnostic x-ray digital imaging system workstation application software :
  • ,
  • Diagnostic x-ray digital imaging system workstation application software :
Icare Finland OyÄyritie 22

Vantaa
FI-01510

Finland

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202219253
  • Impedance pneumography recording/analysis system :
  • ,
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Personal device holder reusable :
  • ,
  • Ophthalmic tonometer probe non-sterile :
  • ,
  • Ophthalmic tonometer probe sterile :
  • ,
  • Medical equipment clinical data interfacing software :
  • ,
  • Ophthalmic tonometer battery-operated :
ICARE (Hong Kong) Company LimitedRoom 904 9/F Hilder Centre 2 Sung Ping Street
Hung Hom
Hong Kong
Kowloon N/A

China

WILLIAM MORRIS LONDON LIMITEDUK Responsible PersonThe Mill Stortford Road Hatfield Heath

Bishop's Stortford
Hertfordshire CM22 7DL
UK Responsible Person
England United Kingdom
03/10/202223481
  • Spectacle frame :
ICB Medical Distributors PTY LTDUnit 4 / 17 - 19 Marshall Rd

Kirrawee
New South Wales 2232

Australia

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
07/09/202115789
  • Orthotic insole prefabricated non-antimicrobial :
IceMedico ehfGrandagardur 16

Reykjavík
101

Iceland

Regulis Consulting LimitedUK Responsible PersonWessex House Marlow Road

Bourne End
Buckinghamshire SL8 5SP
UK Responsible Person
England United Kingdom
12/29/202121549
  • Salivation stimulation lozenge :
Icentia Inc.2750 Rue Einstein

Québec City
QC G1P 4R1

Canada

Icentia LimitedUK Responsible PersonIT Centre
Innovation Way Heslington
York
YO10 5NP
UK Responsible Person
England United Kingdom
04/17/202113494
  • Hypoallergenic skin adhesive tape :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • Electrocardiographic ambulatory recorder :
  • ,
  • Electrocardiographic long-term ambulatory recording analyser application software :
  • ,
  • Electrocardiograph home-use :
Icle Test LimitedPure Offices Plato Close
Tachbrook Park
Warwick
CV34 6WE

England United Kingdom







10/27/202119622
  • Urine blood IVD kit rapid colorimetric clinical :
Icometrix BVKolonel Begaultlaan 1b/12

Leuven
3012

Belgium

Hardian LtdUK Responsible Personc/o Galloways 3rd Floor 21 Perrymount Road

Haywards Heath
West Sussex RH16 3TP
UK Responsible Person
England United Kingdom
11/16/202222019
  • Radiology DICOM image processing application software :
Iconic Eyecare Limited249 Halesowen Road
GBR
CRADLEY HEATH
West Midlands B64 6JD

England United Kingdom







08/25/991185
  • Prescribed Spectacles :
ICSTHubICST 50 Cathedral Road
CARDIFF
CARDIFF
CF11 9LL

Wales United Kingdom







11/04/202226886
  • Self-care monitoring/reporting software :
ICT Healthcare Technology Solutions B.V.Iepenhoeve 7-11

Nieuwegein
Utrecht 3438 MR

Netherlands

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202216746
  • Obstetrical monitoring/analysis software :
ICU Medical Inc951 Calle Amanecer

San Clemente
California 92673

United States

ICU Medical LimitedUK Responsible Person100 New Bridge Street

London
EC4V 6JA
UK Responsible Person
England United Kingdom
04/12/202224203
  • In-line backflow valve single-use :
  • ,
  • Luer-formatted disinfection cap :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • ENFit/ENFit linear connector :
  • ,
  • Non-ISO80369-standardized small-bore linear connector single-use :
  • ,
  • Luer/Luer linear connector single-use :
  • ,
  • Haemodialysis tubing valve-connector :
  • ,
  • Intravenous line stopcock :
  • ,
  • Invasive-pressure external transducer single-use :
  • ,
  • Invasive blood pressure transducer set :
  • ,
  • Angiography kit :
  • ,
  • Invasive blood pressure monitoring tubing set :
  • ,
  • In-line arterial blood sampling set :
  • ,
  • Contrast medium injection system administration set :
  • ,
  • Fluid transfer set general-purpose :
  • ,
  • Invasive blood pressure transducer set :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Neutral-pressure intravenous line needleless valve-connector :
  • ,
  • Medication transfer set :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Vial/bottle adaptor non-hermetic :
  • ,
  • Intravenous administration tubing extension set :
ICU Medical Inc600 N. Field Drive

Lake Forest
Illinois 60045

United States

ICU Medical LimitedUK Responsible Person100 New Bridge Street

London
EC4V 6JA
UK Responsible Person
England United Kingdom
04/12/202224206
  • Bedside infusion pump single-channel :
  • ,
  • Peripheral vascular intervention infusion catheter :
  • ,
  • Electric infusion pump administration set single-use :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Infusion pump medication-dosage application software :
ICU Medical Inc600 N. Field Drive

Lake Forest
Illinois 60045

United States

ICU Medical LimitedUK Responsible Person100 New Bridge Street

London
EC4V 6JA
UK Responsible Person
England United Kingdom
04/13/202224243
  • Bedside infusion pump single-channel :
  • ,
  • Peripheral vascular intervention infusion catheter :
  • ,
  • Electric infusion pump administration set single-use :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Infusion pump medication-dosage application software :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Infusion pump medication-dosage application software :
ICU Medical Limited100 New Bridge Street

London
EC4V 6JA

England United Kingdom







04/12/202113292
  • Neutral-pressure intravenous line needleless valve-connector :
ICU Medical Pty LimitedUnit U 10-16 South Street

Rydalmere
NSW 2116

Australia

ICU Medical LimitedUK Responsible Person100 New Bridge Street

London
EC4V 6JA
UK Responsible Person
England United Kingdom
04/12/202224204
  • Fluid transfer set general-purpose :
  • ,
  • Basic intravenous administration set noninvasive :
IC! Berlin GmbHWolfener Strabe 32 Berlin
12681 Berlin
Berlin
Berlin 12681

Germany

UK RepMed Ltd.UK Responsible PersonWey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT
UK Responsible Person
England United Kingdom
02/01/202222017
  • Spectacle frame :
Ideal Living LLC14724 Ventura Blvd Suite 200

Sherman Oaks CA
91403

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
11/06/202119281
  • Orthotic insole prefabricated non-antimicrobial :
IDEAL MEDICAL INDUSTRIES CO. LTDLUTIAN BASE POYANG INDUSTRY ZONE POYANG

SHANGRAO
JIANGXI 333100

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202217634
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex surgical glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex surgical glove powdered :
Ideal Profile Ltd16 Lawrence Close Barton Seagrave

Kettering
Northamptonshire NN15 5EY

United Kingdom







01/21/20134099
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Partial denture :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental implantation drilling template custom-made :
  • ,
  • Orthognathic surgery intraoperative occlusal positioner :
  • ,
  • Orthodontic habit prevention/breaking appliance bonded :
  • ,
  • Orthodontic habit prevention/breaking appliance self-removable :
  • ,
  • Orthodontic palate expander/teeth aligner bonded :
  • ,
  • Orthodontic palate expander/teeth aligner self-removable :
  • ,
  • Orthodontic appliance positioning tray :
IdealMed LimitedUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ

England United Kingdom







04/09/202213205
  • External orthopaedic fixation system single-use :
IDION MEDICAL CO. LTD.Quyuan Road 519 Industry Area Wukang Town

Deqing
Zhejiang 313200,

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
01/31/202222521
  • Medicine cup reusable :
IDL biotechIDL Biotech PO BOX 11151
Karlsbodavagen 39
Bromma
SE 161 11

Sweden

Rock MedicalUK Responsible PersonMelton Lodge New Road

Hurley
SL6 5LN
UK Responsible Person
England United Kingdom
10/28/202218621
  • Bladder tumour associated antigen IVD kit rapid ICT clinical :
IDMEDHôtel Technoptic 2 Rue Marc Donadille

MARSEILLE
13013

France

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
08/01/202216838
  • Neuromuscular transmission electrical skin sensor :
  • ,
  • Neuromuscular transmission electrical skin sensor :
  • ,
  • Neuromuscular transmission electrical skin sensor :
  • ,
  • Pupillograph :
  • ,
  • Pupillograph :
  • ,
  • Neuromuscular transmission electrical skin sensor :
iDoc24 ABBerzeliigatan 25

Gothenburg
41253

Sweden

Easy Medical Device LimitedUK Responsible Person125 Deansgate

Manchester
M3 2LH
UK Responsible Person
Wales United Kingdom
11/14/202226933
  • Multidisciplinary medical image management software :
Idoman TeorantaIdoman Teoranta Kilateeaun

Tourmakeady
County Mayo F12 PK75

Ireland

Mosaic Surgical LTDUK Responsible Person9 York Way

High Wycombe
HP12 3PY
UK Responsible Person
England United Kingdom
01/21/202111685
  • Circulating-fluid endometrial-ablation catheter :
IDS LTD.194 Simgung-ro Gwangtan-myeon Paju-si Gyeonggi-do 10952 Republic of Korea

Paju-si
Gyeonggi-do 10952

South Korea

CMC Medical Devices LTDUK Responsible PersonOffice 32 19-21 Crawford Street

London
W1H 1PJ
UK Responsible Person
United Kingdom
10/03/202219604
  • General/multiple surgical frequency-doubled solid-state laser system :
  • ,
  • General/multiple surgical diode laser system :
  • ,
  • General/multiple surgical carbon dioxide laser system :
  • ,
  • Intense pulsed light skin surface treatment system :
  • ,
  • Ultrasonic skin contouring system :
  • ,
  • Radio-frequency skin contouring system :
IEM GmbHGewerbepark Brand 42

Aachen
52078 Aachen

Germany

Numed Holdings Ltd t/a Numed HealthcareUK Responsible PersonAlliance House Roman Ridge Road

Sheffield
S9 1GB
UK Responsible Person
England United Kingdom
07/29/202116385
  • Blood pressure ambulatory recorder :
  • ,
  • Telemetric sphygmomanometer :
Ieso Digital Health LimitedThe Jeffreys Building Cowley Rd Milton

Cambridge
Cambridgeshire CB4 0DS

England United Kingdom







04/14/202213309
  • Psychological assessment software :
IGEA S.p.A.Via Parmenide 10a

Carpi
Modena 41012

Italy

IGEA Spa Branch UKUK Responsible PersonParkhill Business Centre Walton Road

Wetherby
West Yorkshire LS22 5DZ
UK Responsible Person
England United Kingdom
10/18/202218601
  • Hand-held deep-tissue electromagnetic stimulator :
  • ,
  • Bone growth ultrasonic stimulator :
  • ,
  • Patient-worn bone growth electromagnetic stimulator :
  • ,
  • Electroporation therapy system probe non-endoscopic :
  • ,
  • Electroporation therapy system non-endoscopic needle electrode :
  • ,
  • Electroporation therapy system probe endoscopic :
  • ,
  • Electroporation therapy system generator :
  • ,
  • Electroporation therapy system generator :
IHSS LimitedUnit 9 Premier Park Road Park Royal

London
NW107NZ

United Kingdom







04/05/20165477
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
  • ,
  • Endoscopes/Endoscopic Instruments And Accessories :
Ilasco LimitedNasmyth Road

Glenrothes
Fife KY6 2SD

Scotland United Kingdom







06/22/202212248
  • Patient isolation tent canopy :
  • ,
  • Isolation gown single-use :
iLine Microsystems S.L.Paseo Mikeletegi 69 20009

Donostia
Guipuzkoa 20009

Spain

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202216461
  • Coagulation analyser IVD home-use battery-powered :
  • ,
  • Prothrombin time (PT) IVD kit rapid clotting clinical :
  • ,
  • Prothrombin time (PT) IVD kit rapid clotting clinical :
  • ,
  • Coagulation analyser IVD home-use battery-powered :
  • ,
  • Prothrombin time (PT) IVD control :
illuco102-304 SK Ventium 166 Gosan-ro

Gunpo-si
15850

South Korea

Athrodax Healthcare International LtdUK Responsible Personunit 1 Hawthorn business park

Drybrook
Gloucestershire gl17 9hp
UK Responsible Person
England United Kingdom
09/09/202225863
  • Dermatoscope optical :
Illumina Inc.5200 Illumina Way

San Diego
CA 92122

United States

Illumina Cambridge LimitedUK Responsible PersonIllumina Centre 19 Granta Park

Cambridge
CB21 6DF
UK Responsible Person
England United Kingdom
04/21/202113647
  • Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT) :
  • ,
  • Cystic fibrosis IVD kit multiplex :
  • ,
  • Nucleic acid sequence analyser IVD next-generation sequencing (NGS) :
  • ,
  • Nucleic acid sequencing reagent kit IVD :
  • ,
  • Multiple congenital aneuploidy screening IVD kit nucleic acid technique (NAT) :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Cancer-related multiple gene mutation profile IVD control :
  • ,
  • Nucleic acid sequence analyser IVD next-generation sequencing (NGS) :
  • ,
  • Nucleic acid sequencing reagent kit IVD :
  • ,
  • Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
iLsa DiagnosticRue de la comtesse

Marchaux
F.25640

France

Pro-Lab DiagnosticsUK Responsible Person3 Bassendale Road

Bromborough
Wirral CH62 3QL
UK Responsible Person
England United Kingdom
uksupport@pro-lab.com
08/17/202225536
  • Clinical laboratory analyser/instrument control unit IVD :
iLumi Sciences Inc.4150 Lafayette Center Drive Suite 500

Chantilly Virginia
20151

United States

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
03/02/202223335
  • Root canal post preformed :
IM Med Ltd1B Pembroke Avenue Waterbeach

Cambridge
CB25 9QP

England United Kingdom
01223 440475
quality@im-med.com






11/01/20176287
  • Endoscope flushing adaptor reusable :
  • ,
  • Endoscope clean-storage system :
  • ,
  • Medical device cleaning agent :
  • ,
  • Medical device disinfection agent :
IMACTIS® SAS20 Rue du Tour de l’Eau

SAINT-MARTIN-D’HERES
38400

France

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
06/03/202115143
  • Electromechanical device/system transport trolley :
  • ,
  • Electromagnetic surgical navigation device tracking system :
  • ,
  • Electromagnetic surgical navigation device tracking system :
  • ,
  • Robotic surgical navigation system : Robotic surgical navigation system Conformity Assessment Certificate Expired
  • ,
  • Electromagnetic surgical navigation device tracking system : Electromagnetic surgical navigation device tracking system Conformity Assessment Certificate Expired
  • ,
  • Electromagnetic surgical navigation device tracking system :
  • ,
  • Electromechanical device/system transport trolley :
  • ,
  • Electromagnetic surgical navigation device tracking system :
  • ,
  • Robotic surgical navigation system :
image dental laboratory164 Upholland Road Billinge

Wigan
Lancashire WN5 7DL

United Kingdom







11/02/20155309
  • Ceramic dental inlay :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental veneer professional :
  • ,
  • Gold dental inlay :
  • ,
  • Orthodontic retainer :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Teeth whitening tray :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Temporary dental crown/bridge resin :
IMAGE Information Systems Europe GmbHLange Strasse 16

Rostock
Mecklenburg-West Pomerania 18055

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202215795
  • Radiology picture archiving and communication system digital archive device :
  • ,
  • Radiology picture archiving and communication system digital archive device :
Imaginable LtdThe Old Library Trinity Road

Bristol
BS20NW

United Kingdom







07/16/20198742
  • Wheelchair electric-motor-driven attendant/occupant-controlled powered-steering non-collapsible :
Imaging Biometrics LLC13416 Watertown Plank Road Suite 260

Elm Grove
Wisconsin 53122

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
01/19/202221375
  • Diagnostic x-ray digital imaging system workstation application software :
Imaxeon Pty LtdUnit 1 38-46 South Street

Rydalmere
2116

Australia

Bayer plcUK Responsible Person400 South Oak Way Green Park

READING
Berkshire RG2 6AD
UK Responsible Person
United Kingdom
07/20/202116083
  • Angiographic syringe :
  • ,
  • Angiographic syringe :
  • ,
  • Radiographic procedure tubing :
  • ,
  • Radiographic procedure tubing :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • Radiographic procedure tubing :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • Angiographic syringe :
Imbio LLC1015 Glenwood Avenue

Minneapolis
Minnesota 55405

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/05/202118715
  • X-ray image interpretive software :
IMDS Operations B.V.Ceintuurbaan Noord 150

Roden
9301 NZ

Netherlands

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
04/29/202114204
  • Vascular guide-catheter single-use : Vascular guide-catheter single-use Conformity Assessment Certificate Expired
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • Coronary angioplasty balloon catheter basic : Coronary angioplasty balloon catheter basic Conformity Assessment Certificate Expired
  • ,
  • Peripheral angioplasty balloon catheter basic : Peripheral angioplasty balloon catheter basic Conformity Assessment Certificate Expired
  • ,
  • Coronary angioplasty balloon catheter basic :
iMDsoft Ltd.Kiryat Atidim #4 P. O. Box 58178

Tel Aviv
6158101

Israel

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
06/22/202115254
  • Patient health record information system application software :
IMEDICOM Co Ltd#612 172 LS-ro Grunpo-si

Gyeonggi-do
15807

South Korea

SAFE ORTHOPAEDICS LtdUK Responsible Person23 Copenhagen Street

London
N1 0JB
UK Responsible Person
England United Kingdom
04/27/202213870
  • Balloon kyphoplasty kit :
IMEDICOM Co. Ltd.#612 #709 #804 #815 172 LS-ro

Gunpo-si
Gyeonggi-do 15807

South Korea

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/01/202118620
  • Bone/joint surgical power tool motor pneumatic :
  • ,
  • Surgical saw blade reciprocating single-use :
  • ,
  • Cranial bur single-use :
  • ,
  • Surgical saw blade oscillating single-use :
  • ,
  • Balloon kyphoplasty kit :
  • ,
  • Epidural/intrathecal anaesthesia set non-medicated :
  • ,
  • Endoscopic electrosurgical electrode bipolar single-use :
  • ,
  • Flexible fibreoptic epiduroscope :
  • ,
  • Multi-purpose surgical power tool system rechargeable battery-powered :
  • ,
  • Epidural anaesthesia set medicated :
  • ,
  • Neurosurgical procedure kit non-medicated single-use :
  • ,
  • Balloon kyphoplasty kit :
IMedis-AI LtdOpenheimer 2

Rehovot
-

Israel

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
07/04/202225183
  • Radiology information system :
IMEI LTDHalsgrove House Lower Moor Way

Tiverton
Devon EX16 6SS

England United Kingdom







06/18/202211838
  • Surgical/medical face mask single-use :
  • ,
  • Surgical/medical face mask single-use :
IMERA.AI LimitedOffice 223e Building 3 North London Business Park
Oakleigh Road South
London
N11 1GN

England United Kingdom







10/19/202119451
  • X-ray image interpretive software :
IMMCO Diagnostics60 Pineview Drive

Amherst
New York 14228

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/13/202224226
  • Multiple clinical chemistry protein IVD kit immunoblot :
  • ,
  • Multiple autoimmune disease-associated antibody screening IVD kit fluorescent immunoassay :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Buffered wash solution IVD manual :
  • ,
  • Negative control immunoglobulin IVD :
  • ,
  • Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Skin antibody IVD kit fluorescent immunoassay :
  • ,
  • Skeletal muscle antibody IVD reagent :
  • ,
  • Rheumatoid factor IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD reagent :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassay :
  • ,
  • Native DNA antibody (anti-nDNA) IVD kit fluorescent immunoassay :
  • ,
  • Multiple myocardium antibody IVD reagent :
  • ,
  • Myelin-associated glycoprotein antibody (anti-MAG) IVD fluorescent immunoassay :
  • ,
  • Islet cell antibody IVD reagent :
  • ,
  • Islet cell antibody IVD kit fluorescent immunoassay :
  • ,
  • Multiple neurological disease-associated antibody IVD kit fluorescent immunoassay :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD reagent :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit fluorescent immunoassay :
  • ,
  • Endomysium antibody (EMA) IVD reagent :
  • ,
  • Endomysium antibody (EMA) IVD kit fluorescent immunoassay :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD reagent :
  • ,
  • Adrenal antibody IVD reagent :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD reagent :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassay :
  • ,
  • Biological stain IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD :
  • ,
  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD :
  • ,
  • Microscope slide coverslip IVD :
  • ,
  • Hu antibody (anti-Hu) IVD reagent :
  • ,
  • Yo antibody IVD control :
Immucor GTI Diagnostics Inc.20925 Crossroad Circle

Waukesha
Wisconsin 53186

United States

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
08/10/202116699
  • Coagulation factor VIII IVD kit chromogenic :
  • ,
  • Platelet factor 4 IVD kit enzyme immunoassay (EIA) :
  • ,
  • HLA class I antigen tissue typing IVD kit multiplex :
  • ,
  • HLA class II antigen tissue typing IVD kit multiplex :
  • ,
  • Complement reagent IVD :
  • ,
  • HLA class I & II antigen tissue typing IVD kit multiplex :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple human platelet antigen (HPA) typing IVD kit multiplex :
  • ,
  • HLA class I antibody screening IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human platelet antigen (HPA) multiple antibody screening/identification IVD kit multiplex :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Human platelet antigen (HPA) multiple antibody screening/identification IVD kit enzyme immunoassay (EIA) :
Immucor Inc.3130 Gateaway Drive

Norcross
Georgia 30071

United States

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
04/27/202114003
  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD kit agglutination :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Antibody identification panel reagent red blood cell IVD kit agglutination :
  • ,
  • Solid-phase red blood cell adherence antibody/antigen IVD :
  • ,
  • Immunoglobulin-sensitized reagent red blood cell IVD control :
  • ,
  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD :
  • ,
  • Anti-Jk^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Jk^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Fy^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Fy^b red blood cell grouping IVD antibody :
  • ,
  • Bovine serum albumin (BSA) immunohaematology reagent IVD :
  • ,
  • Polyspecific antihuman globulin/complement IVD antibody :
  • ,
  • Foeto-maternal haemorrhage/Kleihauer test IVD reagent :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG)/IgM antibody IVD kit solid-phase red blood cell adherence :
  • ,
  • Cytomegalovirus (CMV) total antibody IVD control :
  • ,
  • Cytomegalovirus (CMV) total antibody IVD reagent :
  • ,
  • Polyethylene glycol (PEG) immunohaematology reagent IVD :
  • ,
  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD antibody :
  • ,
  • Pooled antibody screening reagent red blood cell IVD antigen :
  • ,
  • Antibody screening reagent red blood cell IVD kit agglutination :
  • ,
  • P1 blood group substance reagent IVD :
  • ,
  • Lewis blood group substance reagent IVD :
  • ,
  • Microplate IVD :
  • ,
  • Anti-k (KEL002) red blood cell grouping IVD antibody :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Immunohaematology/blood bank analyser IVD :
  • ,
  • Human platelet antigen (HPA) multiple antibody screening/identification IVD reagent :
  • ,
  • Human platelet antigen (HPA) multiple antibody screening/identification IVD control :
  • ,
  • Cell preservation/storage/dilution solution IVD :
  • ,
  • Red cell antibody eluting IVD kit :
  • ,
  • Papain immunohaematology reagent IVD :
  • ,
  • Monospecific anti-complement component C3d (anti-C3d) IVD antibody :
  • ,
  • Ficin immunohaematology reagent IVD :
  • ,
  • Bromelin immunohaematology reagent IVD :
  • ,
  • Anti-S [MNS004] red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS003] red blood cell grouping IVD antibody :
  • ,
  • Anti-Le^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Le^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Kp^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Kp^a red blood cell grouping IVD antibody :
  • ,
  • Anti-C^w red blood cell grouping IVD antibody :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Buffered isotonic saline reagent IVD :
  • ,
  • Multiple immunohaematology test IVD control :
IMMUCOR Medizinische Diagnostik GmbHRobert-Bosch-Strasse 32

Dreieich
63303

Germany

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
04/26/202113903
  • Anti-C [RH002] red blood cell grouping IVD antibody :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Anti-C [RH004] red blood cell grouping IVD antibody :
  • ,
  • Anti-E [RH003] red blood cell grouping IVD antibody :
  • ,
  • Anti-E [RH005] red blood cell grouping IVD antibody :
  • ,
  • Anti-Jk^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Rh(D) red blood cell grouping IVD antibody :
  • ,
  • Polyspecific antihuman globulin/complement IVD antibody :
  • ,
  • Anti-Jk^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Fy^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Fy^a red blood cell grouping IVD antibody :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Anti-A red blood cell grouping IVD antibody :
  • ,
  • Anti-CDE red blood cell grouping IVD antibody :
  • ,
  • Anti-AB red blood cell grouping IVD antibody :
  • ,
  • Anti-AB red blood cell grouping IVD antibody :
  • ,
  • Anti-B red blood cell grouping IVD antibody :
  • ,
  • Buffered isotonic saline reagent IVD :
  • ,
  • Anti-H red blood cell grouping IVD lectin :
  • ,
  • Anti-H red blood cell grouping IVD antibody :
  • ,
  • Anti-A red blood cell subtype differentiation reagent IVD :
  • ,
  • Anti-Wr^a red blood cell grouping IVD antibody :
  • ,
  • Anti-A1 red blood cell grouping IVD lectin :
  • ,
  • Anti-C^w red blood cell grouping IVD antibody :
  • ,
  • Anti-M red blood cell grouping IVD antibody :
  • ,
  • Anti-N red blood cell grouping IVD antibody :
  • ,
  • Anti-P1 red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS003] red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS004] red blood cell grouping IVD antibody :
  • ,
  • Bromelin immunohaematology reagent IVD :
  • ,
  • Blood group/antibody screening analyser IVD :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Anti-k (KEL002) red blood cell grouping IVD antibody :
  • ,
  • Anti-K (KEL001) red blood cell grouping IVD antibody :
Immunalysis Corporation829 Towne Center Drive

Pomona
California 91767

United States

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
11/01/202119091
  • 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD calibrator :
  • ,
  • 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD control :
  • ,
  • 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • 6-Acetyl morphine IVD calibrator :
  • ,
  • 6-Acetyl morphine IVD control :
  • ,
  • 6-Acetyl morphine IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amphetamine-specific IVD calibrator :
  • ,
  • Amphetamine-specific IVD kit enzyme immunoassay (EIA) :
  • ,
  • Buprenorphine IVD control :
  • ,
  • Buprenorphine IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cannabinoid/cannabinoid metabolite IVD calibrator :
  • ,
  • Cannabinoid/cannabinoid metabolite IVD control :
  • ,
  • Ethyl glucuronide (EtG) IVD calibrator :
  • ,
  • Ethyl glucuronide (EtG) IVD control :
  • ,
  • Ethyl glucuronide (EtG) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Fentanyl IVD calibrator :
  • ,
  • Fentanyl IVD control :
  • ,
  • Ketamine/ketamine metabolite IVD calibrator :
  • ,
  • Amphetamine-specific IVD control :
  • ,
  • Ketamine/ketamine metabolite IVD control :
  • ,
  • Morphine/morphine metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Oxycodone IVD calibrator :
  • ,
  • Oxycodone IVD control :
  • ,
  • Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD calibrator :
  • ,
  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD control :
  • ,
  • Tapentadol IVD calibrator :
  • ,
  • Tapentadol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tramadol IVD calibrator :
  • ,
  • Tramadol IVD control :
  • ,
  • Buprenorphine IVD calibrator :
  • ,
  • Methamphetamine-specific IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tapentadol IVD control :
  • ,
  • Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Benzodiazepine group IVD kit enzyme immunoassay (EIA) :
  • ,
  • Opiate/opiate metabolite IVD calibrator :
  • ,
  • Barbiturate IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tramadol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tramadol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Fentanyl IVD kit enzyme immunoassay (EIA) :
  • ,
  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Oxycodone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Cotinine (nicotine metabolite) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple antidepressant therapeutic drug monitoring IVD reagent :
  • ,
  • Methadone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Zolpidem IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cannabinoid/cannabinoid metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Salicylate IVD kit enzyme immunoassay (EIA) :
  • ,
  • Oral/upper respiratory tract specimen collection kit :
Immundiagnostik AGStubenwald-Allee 8a

Bensheim
64625

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
05/24/202224733
  • 125-Dihydroxy vitamin D3 IVD reagent :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Zonulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Retinol binding protein IVD reagent :
  • ,
  • Total immunoglobulin E (IgE total) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Myeloperoxidase (MPO) IVD kit enzyme immunoassay :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Eosinophil-derived neurotoxin (EDN) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Neutrophil elastase IVD kit enzyme immunoassay (EIA) :
  • ,
  • Pancreatic elastase (PE) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Faecal specimen collection kit IVD clinical :
  • ,
  • Faecal specimen container IVD transport buffer/medium :
  • ,
  • Kynurenine IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tryptophan IVD kit enzyme immunoassay (EIA) :
  • ,
  • Haemoglobin detection IVD reagent :
  • ,
  • Total bile acid IVD reagent :
  • ,
  • Biotin (vitamin H) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Secretory immunoglobulin A (secretory IgA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • TNF-alpha IVD kit enzyme immunoassay (EIA) :
  • ,
  • Vedolizumab antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • TNF-alpha inhibitor antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • TNF-alpha inhibitor therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Vedolizumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ustekinumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ustekinumab antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Calprotectin IVD kit enzyme immunoassay (EIA) :
  • ,
  • 125-Dihydroxy vitamin D3 IVD reagent :
  • ,
  • S100 calcium-binding protein A12 (S100A12) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Calprotectin IVD kit enzyme immunoassay (EIA) :
Immunexpress Inc.425 Pointus Ave Suite 470

Seattle
WA 98109

United States

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
04/15/202113432
  • Reverse transcription reagent kit IVD :
Immunodiagnostic Systems France42 Rue Stephane Mazeau

Pouilly-en-Auxois
21320

France

Immunodiagnostic Systems LimitedUK Responsible Person10 Didcot Way Boldon Business Park

Boldon
Tyne & Wear NE35 9PD
UK Responsible Person
United Kingdom
02/01/202221989
  • Multichannel immunoassay analyser IVD semi-automated :
Immunodiagnostic Systems Limited10 Didcot Way Boldon Business Park

Boldon
Tyne & Wear NE35 9PD

United Kingdom







04/01/20157214
  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD kit chemiluminescent immunoassay :
  • ,
  • 25-Hydroxy vitamin D3 IVD kit radioimmunoassay :
  • ,
  • Renin IVD control :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD control :
  • ,
  • Gliadin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Tissue transglutaminase antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Gliadin antibody IVD control :
  • ,
  • Anticardiolipin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Beta-2-glycoprotein I antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Beta-2-glycoprotein I antibody IVD control :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD kit chemiluminescent immunoassay :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassay :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin-like growth factor I (IGF1) IVD control :
  • ,
  • Tartrate resistant acid phosphatase (TRAP) IVD kit chemiluminescent immunoassay :
  • ,
  • Tartrate resistant acid phosphatase (TRAP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD kit chemiluminescent immunoassay :
  • ,
  • Total testosterone IVD control :
  • ,
  • Free testosterone IVD reagent :
  • ,
  • Free testosterone IVD control :
  • ,
  • Sex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassay :
  • ,
  • Sex hormone binding globulin (SHBG) IVD control :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD kit chemiluminescent immunoassay :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD control :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD control :
  • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD control :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD control :
  • ,
  • Thyroglobulin antibody IVD control :
  • ,
  • Total immunoglobulin E (IgE total) IVD control :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD control :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD control :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD kit chemiluminescent immunoassay :
  • ,
  • Thyroglobulin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Tissue transglutaminase antibody IVD control :
  • ,
  • Anticardiolipin antibody IVD control :
  • ,
  • SSA/Ro antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Tartrate resistant acid phosphatase (TRAP) IVD control :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD control :
  • ,
  • Antinuclear antibody kit :
  • ,
  • Tissue transglutaminase antibody IVD control :
  • ,
  • 125-Dihydroxy vitamin D3 IVD kit radioimmunoassay :
  • ,
  • 125-Dihydroxy vitamin D3 IVD control :
  • ,
  • 125-Dihydroxy vitamin D3 IVD kit chemiluminescent immunoassay :
  • ,
  • 125-Dihydroxy vitamin D3 IVD reagent :
  • ,
  • 25-Hydroxy vitamin D3 IVD calibrator :
  • ,
  • 25-Hydroxy vitamin D3 IVD control :
  • ,
  • 25-Hydroxy vitamin D3 IVD reagent :
  • ,
  • Tissue transglutaminase antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD kit chemiluminescent immunoassay :
  • ,
  • 17-Hydroxyprogesterone IVD kit chemiluminescent immunoassay :
  • ,
  • Extractable nuclear antigen kit :
  • ,
  • Anti-double-stranded DNA antibody kit :
  • ,
  • Anti-SSB/La antibody kit :
  • ,
  • Anti-smooth muscle antibody kit :
  • ,
  • U1-small nuclear ribonucleoprotein antibody kit :
  • ,
  • Scleroderma-70 antibody kit :
  • ,
  • Jo-1 antibody kit :
  • ,
  • CENP-antibody kit :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD control :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD control :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD kit chemiluminescent immunoassay :
  • ,
  • Parathyroid hormone (PTH) IVD kit chemiluminescent immunoassay :
  • ,
  • Osteocalcin IVD control :
  • ,
  • Osteocalcin IVD kit chemiluminescent immunoassay :
  • ,
  • Osteocalcin IVD reagent :
  • ,
  • Procollagen type I C-terminal propeptide (PICP) IVD control :
  • ,
  • Procollagen type I C-terminal propeptide (PICP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Procollagen type I C-terminal propeptide (PICP) IVD reagent :
  • ,
  • Procollagen type I N-terminal propeptide (PINP) IVD kit radioimmunoassay :
  • ,
  • Parathyroid hormone (PTH) IVD control :
  • ,
  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD kit radioimmunoassay :
  • ,
  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD control :
  • ,
  • Aldosterone IVD kit chemiluminescent immunoassay :
  • ,
  • Aldosterone IVD control :
  • ,
  • Angiotensin converting enzyme (ACE) IVD kit enzyme spectrophotometry :
  • ,
  • Bone alkaline phosphatase (BALP) IVD control :
  • ,
  • Bone alkaline phosphatase (BALP) IVD kit chemiluminescent immunoassay :
  • ,
  • Bone alkaline phosphatase (BALP) IVD reagent :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Human growth hormone (HGH) IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin-like growth factor I (IGF1) IVD kit chemiluminescent immunoassay :
  • ,
  • Renin IVD kit chemiluminescent immunoassay :
  • ,
  • Procollagen type I N-terminal propeptide (PINP) IVD control :
  • ,
  • Calprotectin IVD kit chemiluminescent immunoassay :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Calprotectin IVD control :
  • ,
  • Rectal/faecal specimen collection kit :
  • ,
  • Free cortisol IVD kit chemiluminescent immunoassay :
  • ,
  • Free cortisol IVD calibrator :
  • ,
  • Free cortisol IVD control :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD calibrator :
  • ,
  • Cartilage oligomeric matrix protein (COMP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Ribosomal phosphoprotein antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Nucleosomal antibody IVD reagent :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory :
Immunodiagnostic Systems S.A.Rue Ernest Solvay 101

Liege
4000

Belgium

Immunodiagnostic Systems LimitedUK Responsible Person10 Didcot Way Boldon Business Park

Boldon
Tyne & Wear NE35 9PD
UK Responsible Person
United Kingdom
02/01/202221985
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Multichannel immunoassay analyser IVD semi-automated :
ImmunoIVD ABBox 1140

Nacka Strand
13126

Sweden

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
12/13/202120506
  • T-cell receptor excision circle (TREC) IVD kit nucleic acid technique (NAT) :
ImmunoServ LtdGreenmeadow Springs Business Park Unit 8 Cae Gwyrdd

Tongwynlais
Cardiff CF15 7AB

Wales United Kingdom







04/05/202224058
  • Home blood collection kit IVD :
Immunostics Inc.38 Industrial Way East Suite 1

Eatontown
NJ 07724

United States

IVDeology UKRP LtdUK Responsible Person22-23 The Joiners Shop Historic Dockyard
Chatham
Rochester
Kent ME4 4TZ
UK Responsible Person
England United Kingdom
11/10/202226884
  • Faecal occult blood IVD kit colorimetric dipstick :
Immunotech S.A.S.130 avenue de Lattre de Tassigny

Marseilles
13276

France

Beckman Coulter UK LtdUK Responsible PersonOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU
UK Responsible Person
United Kingdom
04/19/202220820
  • CD11b cell marker IVD antibody :
  • ,
  • CD11c cell marker IVD antibody :
  • ,
  • CD15 cell marker IVD antibody :
  • ,
  • CD20 cell marker IVD antibody :
  • ,
  • CD22 cell marker IVD antibody :
  • ,
  • CD23 cell marker IVD antibody :
  • ,
  • CD25 cell marker IVD antibody :
  • ,
  • CD27 cell marker IVD antibody :
  • ,
  • CD33 cell marker IVD antibody :
  • ,
  • CD38 cell marker IVD antibody :
  • ,
  • CD41 cell marker IVD antibody :
  • ,
  • CD43 cell marker IVD antibody :
  • ,
  • CD45RA cell marker IVD antibody :
  • ,
  • CD55 red cell antigen IVD antibody :
  • ,
  • CD57 natural killer cell marker IVD antibody :
  • ,
  • CD59 red cell antigen IVD antibody :
  • ,
  • CD61 platelet glycoprotein IIIa marker IVD antibody :
  • ,
  • CD64 cell marker IVD antibody :
  • ,
  • CD69 cell marker IVD antibody :
  • ,
  • CD71 cell marker IVD antibody :
  • ,
  • Multiple CD cell marker IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
  • ,
  • CD79b cell marker IVD antibody :
  • ,
  • CD117 (c-kit) cell marker IVD antibody :
  • ,
  • Leukocyte myeloperoxidase (MPO) IVD antibody :
  • ,
  • T-cell antigen receptor (TCR) gamma/delta chain IVD antibody :
  • ,
  • CD103 cell marker IVD antibody :
  • ,
  • CD105 endoglin marker IVD antibody :
  • ,
  • Terminal deoxynucleotidyl transferase (TdT) IVD antibody :
  • ,
  • CD65 cell marker IVD antibody :
  • ,
  • T-cell antigen receptor (TCR) alpha/beta chain IVD antibody :
  • ,
  • CD36 cell marker IVD antibody :
  • ,
  • CD127 cell marker IVD antibody :
  • ,
  • CD24 cell marker IVD antibody :
  • ,
  • Neural/glial antigen 2 (NG2) cell maker IVD antibody :
  • ,
  • CD203 cell marker IVD antibody :
  • ,
  • CD200 cell marker IVD antibody :
  • ,
  • CD63 cell marker IVD antibody :
  • ,
  • Cell viability solution IVD :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD calibrator :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD control :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD reagent :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassay :
  • ,
  • Procalcitonin (PCT) IVD kit chemiluminescent immunoassay :
  • ,
  • Troponin I IVD kit chemiluminescent immunoassay :
  • ,
  • White blood cell count IVD kit cell count :
  • ,
  • CD2 T-cell marker IVD antibody :
  • ,
  • CD3 cell marker IVD antibody :
  • ,
  • CD4 cell marker IVD antibody :
  • ,
  • CD8 cell marker IVD antibody :
  • ,
  • CD10 cell marker IVD antibody :
  • ,
  • CD5 cell marker IVD antibody :
  • ,
  • CD7 cell marker IVD antibody :
  • ,
  • CD13 cell marker IVD antibody :
  • ,
  • CD14 cell marker IVD antibody :
  • ,
  • CD16 cell marker IVD antibody :
  • ,
  • CD19 cell marker IVD antibody :
  • ,
  • CD34 cell marker IVD antibody :
  • ,
  • CD45 leukocyte common antigen cell marker IVD antibody :
  • ,
  • CD45RO cell marker IVD antibody :
  • ,
  • CD56 neural cell adhesion molecule-1 (NCAM-1) IVD antibody :
  • ,
  • CD79a cell marker IVD antibody :
  • ,
  • CD138 cell marker IVD antibody :
  • ,
  • CD235a glycophorin A red blood cell marker IVD antibody :
  • ,
  • HLA-DR antigen tissue typing IVD antibody :
  • ,
  • CD62P cell marker IVD antibody :
  • ,
  • CD1a cell marker IVD antibody :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple CD cell marker IVD antibody :
  • ,
  • Multiple CD cell marker IVD control :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD antibody :
Immunotech s.r.oRadiova 1122/1 102 00 Prague 10

Prague
10

Czechia

Beckman Coulter UK LtdUK Responsible PersonOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU
UK Responsible Person
United Kingdom
04/19/202216643
  • Inhibin A IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ferritin IVD kit radioimmunoassay :
  • ,
  • 17-Hydroxyprogesterone IVD kit radioimmunoassay :
  • ,
  • Aldosterone IVD kit radioimmunoassay :
  • ,
  • C-peptide IVD kit radioimmunoassay :
  • ,
  • Dehydroepiandrosterone (DHEA) IVD kit radioimmunoassay :
  • ,
  • Estradiol (oestradiol) (E2) IVD kit radioimmunoassay :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit radioimmunoassay :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit radioimmunoassay :
  • ,
  • Inhibin B IVD kit enzyme immunoassay (EIA) :
  • ,
  • Inhibin B IVD calibrator :
  • ,
  • Luteinizing hormone (LH) IVD kit radioimmunoassay :
  • ,
  • Parathyroid hormone (PTH) IVD kit radioimmunoassay :
  • ,
  • Parathyroid hormone related peptide (PTHrP) IVD kit radioimmunoassay :
  • ,
  • Progesterone IVD kit radioimmunoassay :
  • ,
  • Prolactin IVD kit radioimmunoassay :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit radioimmunoassay :
  • ,
  • Free thyroxine (FT4) IVD kit radioimmunoassay :
  • ,
  • Free triiodothyronine (FT3) IVD kit radioimmunoassay :
  • ,
  • Beta-2-microglobulin IVD kit radioimmunoassay :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit radioimmunoassay :
  • ,
  • Angiotensin I IVD kit radioimmunoassay :
  • ,
  • Insulin IVD kit radioimmunoassay :
  • ,
  • Total thyroxine (TT4) IVD kit radioimmunoassay :
  • ,
  • Total triiodothyronine (TT3) IVD kit radioimmunoassay :
  • ,
  • Sex hormone binding globulin (SHBG) IVD kit radioimmunoassay :
  • ,
  • Total cortisol IVD kit radioimmunoassay :
  • ,
  • Estrone sulfate (oestrone sulfate) IVD kit radioimmunoassay :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD kit radioimmunoassay :
  • ,
  • Thymidine kinase IVD kit enzyme radiometry :
  • ,
  • Insulin-like growth factor I (IGF1) IVD kit radioimmunoassay :
  • ,
  • Total testosterone IVD kit radioimmunoassay :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD kit radioimmunoassay :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit radioimmunoassay :
  • ,
  • Cancer antigen 125 (CA125) IVD kit radioimmunoassay :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD kit radioimmunoassay :
  • ,
  • Anti-Mullerian hormone (AMH) IVD calibrator :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple glycoprotein hormone alpha-subunit IVD kit radioimmunoassay :
  • ,
  • Histamine antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Renin IVD kit radioimmunoassay :
IMMY Inc.2701 Corporate Centre Dr.

Norman OK
73069

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
01/18/202221320
  • Multiple Aspergillus species antigen IVD kit rapid ICT clinical :
  • ,
  • Cryptococcus neoformans antigen IVD kit rapid agglutination clinical :
  • ,
  • Cryptococcus complex species antigen IVD kit rapid ICT clinical :
ImPACT Applications Inc.2140 Norcor Ave Suite 115

Coralville
Iowa 52241

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
11/24/202220888
  • Cognitive assessment software :
ImpediMed Limited50 Parker Court Unit 1

Pinkenba
QLD 4008

Australia

Sandbourne Medical LimitedUK Responsible PersonFloor 3 33 Park Row

Nottingham
NG1 6EE
UK Responsible Person
England United Kingdom
info@sandbournemedical.co.uk
12/23/202120881
  • Bioelectrical body composition analyser :
  • ,
  • Electrocardiographic electrode single-use :
Imperial College London Centre for Bio-inspired TechnologyImperial College London Centre for Bio-inspired Technology
Exhibition Road South Kensington
London
SW7 2AZ

United Kingdom







04/30/20198619
  • Clinical management support software :
Imperial Smiles ltd8 Dukes Ave

Kingston Upon Thames
Greater London KT2 5QY

England United Kingdom







03/25/202112910
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim wax plate :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Bite registration rim :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made dental anatomy model :
  • ,
  • Dental base plate :
  • ,
  • Dental impression tray material :
Impeto Medical17 rue Campagne Premiere

Paris
75014

France

ADVANCED MEDICAL EQUIPMENT LTDUK Responsible Person9 Donnington Park 85 Birdham Road

Chichester
Sussex PO20 7AJ
UK Responsible Person
England United Kingdom
rosy@advancedmedicalequipment.com
09/05/202225777
  • Skin electrical conductance meter :
ImplanetTechnopole Montesquieu Allée François Magendie

Martillac
33650

France

Osteon Medical LtdUK Responsible Person133 Tame Road Birmingham

Birmingham
B67DG
UK Responsible Person
England United Kingdom
06/23/202225065
  • Bone-screw internal spinal fixation system sterile :
Implant Protesis Dental 2004 S.L.Camí del Mig 71 1º 2ª

Barcelona
08032

Spain

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
04/22/202113683
  • Surgical screwdriver reusable :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant suprastructure permanent preformed : Dental implant suprastructure permanent preformed Conformity Assessment Certificate Expired
  • ,
  • Dental implant suprastructure permanent preformed : Dental implant suprastructure permanent preformed Conformity Assessment Certificate Expired
Implant Solutions Pty Ltd. (T/A Osteon Medical)759-767 Springvale Road

Mulgrave
VICTORIA 3170

Australia

European Device Solutions LtdUK Responsible Person15 COANWOOD DRIVE Whitley Bay

WHITLEY BAY
TYNE AND WEAR NE25 9GB
UK Responsible Person
England United Kingdom
11/02/202226849
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant suprastructure temporary custom-made :
  • ,
  • Dental implant abutment analog scanning :
implantcast GmbHLüneburger Schanze 26
Lüneburger Schanze 26
Buxtehude
21614

Germany

Implantcast UK LtdUK Responsible PersonAquious 3 Aston Cross Business Park Rocky Lane

Birmingham
County (optional) B6 5RQ
UK Responsible Person
England United Kingdom
04/30/202114314
  • Metallic femoral head prosthesis :
  • ,
  • Bipolar femoral head outer component hemiarthroplasty :
  • ,
  • Polyethylene acetabulum prosthesis :
  • ,
  • Metal-backed patella prosthesis :
  • ,
  • Ceramic femoral head prosthesis :
  • ,
  • Polymer orthopaedic cement restrictor non-bioabsorbable sterile :
  • ,
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Ceramic acetabular liner :
  • ,
  • Hip hemiarthroplasty femur prosthesis :
  • ,
  • Implantable orthopaedic fixation device connection screw :
  • ,
  • Internal orthopaedic fixation system cerclage wire/cable sterile :
  • ,
  • Temporary hip prosthesis :
  • ,
  • Orthopaedic cement spacer mould :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Diaphysis prosthesis :
  • ,
  • Knee arthrodesis prosthesis :
  • ,
  • Femoral stem centralizer :
  • ,
  • Acetabular augmentation implant :
  • ,
  • Press-fit femoral stem prosthesis : Press-fit femoral stem prosthesis Conformity Assessment Certificate Expired
  • ,
  • Uncoated knee femur prosthesis metallic : Uncoated knee femur prosthesis metallic Conformity Assessment Certificate Expired
  • ,
  • Knee femur stem prosthesis : Knee femur stem prosthesis Conformity Assessment Certificate Expired
  • ,
  • Knee arthroplasty wedge : Knee arthroplasty wedge Conformity Assessment Certificate Expired
  • ,
  • Press-fit hip femur prosthesis modular : Press-fit hip femur prosthesis modular Conformity Assessment Certificate Expired
  • ,
  • Sleeve femoral/tibial extension coated : Sleeve femoral/tibial extension coated Conformity Assessment Certificate Expired
  • ,
  • Femur/tibia shaft prosthesis : Femur/tibia shaft prosthesis Conformity Assessment Certificate Expired
  • ,
  • Sleeve femoral/tibial extension uncoated : Sleeve femoral/tibial extension uncoated Conformity Assessment Certificate Expired
  • ,
  • Body femoral/tibial extension stem uncoated : Body femoral/tibial extension stem uncoated Conformity Assessment Certificate Expired
  • ,
  • Acetabular liner locking ring : Acetabular liner locking ring Conformity Assessment Certificate Expired
  • ,
  • Knee femur stem/sleeve connector : Knee femur stem/sleeve connector Conformity Assessment Certificate Expired
  • ,
  • Knee tibia prosthesis plug : Knee tibia prosthesis plug Conformity Assessment Certificate Expired
  • ,
  • Metallic acetabular liner : Metallic acetabular liner Conformity Assessment Certificate Expired
  • ,
  • Tibial insert : Tibial insert Conformity Assessment Certificate Expired
  • ,
  • Non-constrained polyethylene acetabular liner : Non-constrained polyethylene acetabular liner Conformity Assessment Certificate Expired
  • ,
  • Uncoated knee tibia prosthesis metallic : Uncoated knee tibia prosthesis metallic Conformity Assessment Certificate Expired
  • ,
  • Rotating hinged total knee prosthesis : Rotating hinged total knee prosthesis Conformity Assessment Certificate Expired
  • ,
  • Coated knee femur prosthesis : Coated knee femur prosthesis Conformity Assessment Certificate Expired
  • ,
  • Trabeculated bicondylar knee femur prosthesis : Trabeculated bicondylar knee femur prosthesis Conformity Assessment Certificate Expired
  • ,
  • Uncoated hip femur prosthesis modular : Uncoated hip femur prosthesis modular Conformity Assessment Certificate Expired
  • ,
  • Coated femoral stem prosthesis modular : Coated femoral stem prosthesis modular Conformity Assessment Certificate Expired
  • ,
  • Coated knee tibia prosthesis : Coated knee tibia prosthesis Conformity Assessment Certificate Expired
  • ,
  • Polyethylene patella prosthesis : Polyethylene patella prosthesis Conformity Assessment Certificate Expired
  • ,
  • Uncoated femoral stem prosthesis modular : Uncoated femoral stem prosthesis modular Conformity Assessment Certificate Expired
  • ,
  • Acetabular shell : Acetabular shell Conformity Assessment Certificate Expired
  • ,
  • Acetabulum prosthesis hole plug : Acetabulum prosthesis hole plug Conformity Assessment Certificate Expired
  • ,
  • Uncoated femoral stem prosthesis one-piece : Uncoated femoral stem prosthesis one-piece Conformity Assessment Certificate Expired
  • ,
  • Constrained polyethylene acetabular liner : Constrained polyethylene acetabular liner Conformity Assessment Certificate Expired
  • ,
  • Bone cap : Bone cap Conformity Assessment Certificate Expired
  • ,
  • Shoulder humeral body prosthesis : Shoulder humeral body prosthesis Conformity Assessment Certificate Expired
  • ,
  • Shoulder prosthesis screw : Shoulder prosthesis screw Conformity Assessment Certificate Expired
  • ,
  • Reverse shoulder prosthesis base plate : Reverse shoulder prosthesis base plate Conformity Assessment Certificate Expired
  • ,
  • Press-fit shoulder humeral stem prosthesis : Press-fit shoulder humeral stem prosthesis Conformity Assessment Certificate Expired
  • ,
  • Stem-fixed humeral head prosthesis : Stem-fixed humeral head prosthesis Conformity Assessment Certificate Expired
  • ,
  • Hinged total elbow prosthesis : Hinged total elbow prosthesis Conformity Assessment Certificate Expired
  • ,
  • Shoulder glenoid fossa prosthesis prefabricated : Shoulder glenoid fossa prosthesis prefabricated Conformity Assessment Certificate Expired
  • ,
  • Total shoulder prosthesis : Total shoulder prosthesis Conformity Assessment Certificate Expired
  • ,
  • Uncoated shoulder humeral stem prosthesis : Uncoated shoulder humeral stem prosthesis Conformity Assessment Certificate Expired
  • ,
  • Total reverse shoulder prosthesis : Total reverse shoulder prosthesis Conformity Assessment Certificate Expired
  • ,
  • Partial shoulder prosthesis : Partial shoulder prosthesis Conformity Assessment Certificate Expired
  • ,
  • Humeral stem extension prosthesis : Humeral stem extension prosthesis Conformity Assessment Certificate Expired
Implantech AssociatesSuite B 6025 Nicolle Street

Ventura
California 93003

United States

Eurosurgical LtdUK Responsible PersonMerrow Business Park
Guildford
Guildford
Surrey GU4 7WA
UK Responsible Person
England United Kingdom
03/29/202113020
  • Malar prosthesis :
  • ,
  • Chin prosthesis :
  • ,
  • Facial mandibular prosthesis :
  • ,
  • Nasal implant synthetic polymer non-bioabsorbable :
  • ,
  • Silicone-block tissue reconstructive material :
  • ,
  • Suction system filter plume particulate :
Implantica CE Reflux LtdSir Temi Zammit Buildings Malta Life Sciences Park

San Gwann
SGN 3000

Malta

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
05/12/202114619
  • Gastro-oesophageal antireflux extraluminal fundal implant :
  • ,
  • Gastro-oesophageal antireflux fundal implant placement tool reusable :
ImplicitCare LLC830 Challenger st Suite 120

Brea
92821

United States

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
11/09/202119327
  • Polyester suture non-bioabsorbable multifilament :
Implicity29 rue du Louvre

Paris
75002

France

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
07/07/202225233
  • Cardiology information system application software :
Impo International LimitedUnit 3 60 Lower Road Harrow

Greater London
HA2 0DH

United Kingdom







03/13/20176074
  • Knee/ankle/foot orthosis :
  • ,
  • Shoulder/elbow/wrist/hand orthosis :
  • ,
  • Arm friction/impact protector :
  • ,
  • Sacroiliac spine orthosis :
  • ,
  • Hot/cold therapy pack reusable :
  • ,
  • Orthopaedic adhesive tape :
  • ,
  • Compression/pressure sock/stocking reusable :
  • ,
  • Hand/finger splint reusable :
  • ,
  • Finger protector reusable :
  • ,
  • Eye patch :
  • ,
  • Wound shield :
  • ,
  • Eye pad :
  • ,
  • Bunion shield :
  • ,
  • Foot friction/impact protector :
  • ,
  • Magnifying spectacles :
  • ,
  • Bed incontinence system :
  • ,
  • Lumbosacral spine orthosis hernia support :
  • ,
  • Tubular support bandage non-latex reusable :
  • ,
  • Compression/pressure tubular garment :
  • ,
  • Finger/hand exerciser :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • First aid absorbent pad/bandage :
  • ,
  • Adhesive bandage :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Skin-cover adhesive strip non-antimicrobial :
  • ,
  • Waterproof skin adhesive tape :
  • ,
  • Absorbent wound compression pad :
  • ,
  • Wound dressing kit non-medicated non-sterile :
  • ,
  • Lice removal/prevention kit :
  • ,
  • Hallux valgus metatarsophalangeal orthosis :
  • ,
  • Orthotic insole prefabricated non-antimicrobial :
  • ,
  • Wheelchair seat cushion :
  • ,
  • Transport wheelchair collapsible :
  • ,
  • Single-base walking stick :
  • ,
  • Tubular bandage applicator :
  • ,
  • Foot cushion :
  • ,
  • Compression/pressure shirt/pants :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Wheelchair crutch/walking stick holder :
  • ,
  • Dental prosthesis/orthodontic appliance cleaning brush :
  • ,
  • Guayule-latex examination/treatment glove non-powdered :
  • ,
  • First aid kit non-medicated reusable :
  • ,
  • Back-filling orthosis :
  • ,
  • Prescription spectacles :
  • ,
  • Cast boot :
  • ,
  • First aid limb splint non-mouldable single-use :
  • ,
  • Basic walking frame non-foldable :
  • ,
  • Multiple-base walking stick :
  • ,
  • Multi-terrain sports wheelchair electric-motor-driven :
  • ,
  • Multi-terrain sports wheelchair attendant/occupant-driven :
  • ,
  • Patient/medical device walker home-use :
Impression Dental Laboratory Ltd26 Castle Hill Road
The Old Police Station
Wigan
Lancashire WN2 4BJ

England United Kingdom
01942 525405
labsupport@impressiondental.co.uk






04/04/20221989
  • Dental Appliances/Prostheses :
Impressions Dental Laboratory Ltd2-4 Derby Road Stapleford

Nottingham
Nottinghamshire NG9 7AA

United Kingdom







02/17/20175873
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Orthodontic retainer :
  • ,
  • Overdenture :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Teeth whitening tray :
  • ,
  • Partial denture :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
IMPROVING MOBILITY DEVELOPMENT S.L.Avda. Mare Nostrum 1 – Bloque 1 puerta 16

Alboraya
46120

Spain

AF PHARMA SERVICE UK LTDUK Responsible PersonSuite 140 Temple Chambers 3-7 Temple Avenue

London
EC4Y 0DA
UK Responsible Person
England United Kingdom
11/28/202227115
  • Adult nappy :
  • ,
  • Mobile patient lifting system electrically-powered :
  • ,
  • Assistive shoehorn/bootjack :
  • ,
  • Assistive toilet :
  • ,
  • Single-base walking stick :
  • ,
  • Elbow crutch :
  • ,
  • Forearm support crutch :
  • ,
  • Axillary crutch :
  • ,
  • Handgrip disability-assistive walker non-powered non-foldable :
  • ,
  • Bedrail :
  • ,
  • Bath hand rail :
  • ,
  • Hand rail :
  • ,
  • Alternating-pressure chair cushion system :
  • ,
  • Patient transfer sliding board :
  • ,
  • Assistive hair-washing/shampooing device :
  • ,
  • Handgrip disability-assistive walker non-powered foldable :
  • ,
  • Multifunction body cushion :
  • ,
  • Bath back rest/seat :
  • ,
  • Walking stick/seat :
  • ,
  • Absorbent underpad non-antimicrobial reusable :
IMS Giotto S.P.A.Via Sagittario 5

Sasso Marconi
Bologna 40037

Italy

QCS International LTD.UK Responsible PersonSuite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ
UK Responsible Person
Scotland United Kingdom
10/11/202118145
  • Mammographic stereotactic biopsy system :
  • ,
  • Mammographic biopsy x-ray table powered :
  • ,
  • Diagnostic x-ray digital imaging system workstation :
  • ,
  • Radiology DICOM image processing application software :
  • ,
  • Diagnostic x-ray digital imaging conversion system :
  • ,
  • Diagnostic x-ray digital imaging system workstation application software :
  • ,
  • Stationary mammographic x-ray system digital :
Imspex Diagnostics LtdT Menter Navigation Park

Abercynon
Rhondda Cynon Taf CF45 4SN

Wales United Kingdom

EU-UK Authorised Representative LtdAuthorised Representative (Northern Ireland) UK Responsible PersonUnit 591 Moat House
54 Bloomfield Avenue
Belfast
BT5 5 AD
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
05/17/202224606
  • Mass spectrometry breath analyser IVD :
IMT Analytics AGGewerbestrasse 8

Buchs
SG 9470

Switzerland

Robin FribergUK Responsible Person104B Elers road

London
W13 9QE
UK Responsible Person
England United Kingdom
07/22/202225335
  • Lung physical simulator :
imtmedical agGewerbestrasse 8

Buchs
SG 9470

Switzerland

Vyaire Medical Products LimitedUK Responsible PersonChineham Gate Chineham Business Park Crockford Lane

Basingstoke
RG24 8NA
UK Responsible Person
England United Kingdom
11/22/202118678
  • Neonatal/adult intensive-care ventilator :
imtmedical Pte. Ltd10 Jalan Kilang Bt Merah Enterprise Centre #07-01

Singapore
159410

Singapore

Vyaire Medical Products LimitedUK Responsible PersonChineham Gate Chineham Business Park Crockford Lane

Basingstoke
RG24 8NA
UK Responsible Person
England United Kingdom
09/15/202117527
  • Breathing circuit gas-sampling/monitoring set :
Imutest LimitedRiverside House Yew Street

Stockport
Cheshire SK4 2HD

England United Kingdom







03/11/202212599
  • Allergen-specific immunoglobulin E (IgE) antibody IVD kit immunochromatographic test (ICT) rapid/self-test :
  • ,
  • Total immunoglobulin E (IgE total) IVD reagent :
In-Align Orthodontic LtdCentury House 100 Menzies Road

Hastings
East Sussex TN38 9BB

United Kingdom







02/27/20198537
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic teeth positioner preformed :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic appliance system bonded :
In Retention2 Garden House Drive Kiveton Park

Sheffield
South Yorkshire S26 6SS

United Kingdom







07/31/20062665
  • Dental Appliances/Prostheses :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic space maintainer :
IN2Bones SAS28 Chemin Du Petit Bois

Ecully
69130

France

Templar Regulatory Consulting Limited UK Responsible PersonNiall House Unit 4 24-26 Boulton Road
Stevenage
Stevenage
Hertfordshire SG14QX
UK Responsible Person
England United Kingdom
07/27/202116279
  • Orthopaedic bone staple non-adjustable :
  • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable sterile :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Cannulated surgical drill bit single-use :
  • ,
  • Cannulated surgical drill bit reusable :
  • ,
  • Surgical implant template single-use :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Subtalar implant non-bioabsorbable :
  • ,
  • Fixed-bearing total ankle prosthesis :
  • ,
  • Tibia nail :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Orthopaedic implant aiming/guiding block reusable :
  • ,
  • Screw extractor reusable :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Orthopaedic x-ray ruler :
  • ,
  • Orthopaedic chisel :
  • ,
  • Bone curette reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Orthopaedic x-ray ruler :
  • ,
  • Orthopaedic instrument extractor :
  • ,
  • Instrument transport trolley system :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Medical ruler reusable :
  • ,
  • Surgical vice bench :
  • ,
  • Instrument transport trolley system :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Interphalangeal joint arthrodesis implant :
In2Bones USA60000 Popular Avenue Suite 115

Memphis
Tennessee 38119

United States

Templar Regulatory Consulting Limited UK Responsible PersonNiall House Unit 4 24-26 Boulton Road
Stevenage
Stevenage
Hertfordshire SG14QX
UK Responsible Person
England United Kingdom
07/07/202115826
  • Partial metatarsophalangeal joint prosthesis :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
Inagene Diagnostics Inc802-2345 Yonge St

Toronto
ON M4P2E5

Canada

JSOBrien Business Solutions LtdUK Responsible Person15 Park Road

Stourbridge
West Midlands DY8 3RS
UK Responsible Person
England United Kingdom
06/16/202220226
  • Human genomic analysis interpretive software IVD :
Inami & Co. Ltd.No 24-2 Hongo 3-Chome Bunkyo-Ku

Tokyo
113-0033

Japan

Grafton Optical Company LimitedUK Responsible PersonUnit 7 River Park Industrial Estate Billet Lane

Berkhamsted
Hertfordshire HP41HL
UK Responsible Person
England United Kingdom
03/09/202223515
  • Perimeter manual :
  • ,
  • Vision testing/training chart :
  • ,
  • Trial lens frame :
  • ,
  • Ophthalmic tonometer line-powered :
Inari Medical9 Parker Suite 100

Irvine
California 92618

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/03/202114354
  • Thrombectomy suction catheter :
  • ,
  • Thrombectomy rotational catheter :
Inavya Ventures Ltd64 Southwark Bridge Road

London
ENGLAND SE1 0AS

United Kingdom







10/17/20188202
  • Clinical information system web-based application software :
InBody Co. Ltd. InBody Bldg. 625 Eonju-ro Gangnam-gu

Seoul
06106

South Korea

InBody UK BRANCH LIMITEDUK Responsible Person11 Phoenix Park Telford Way Stephenson Industrial Estate

Coalville
LE67 3HB
UK Responsible Person
England United Kingdom
06/24/202115471
  • Manual-inflation electronic sphygmomanometer portable :
  • ,
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
  • ,
  • Bioelectrical body composition analyser :
  • ,
  • Skin-cleaning wipe non-sterile :
  • ,
  • Posturography system platform :
  • ,
  • Back/leg/chest dynamometer mechanical :
  • ,
  • Blood pressure cuff reusable :
Incidental LimitedBRUNSWICK DENTAL PRACTICE DARRELL STREET BRUNSWICK VILLAGE

NEWCASTLE UPON TYNE
NE13 7DS

England United Kingdom







09/01/202118213
  • Rubber dam punch :
  • ,
  • Dental matrix band retainer :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental material application tool reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Scalpel handle reusable :
  • ,
  • Dental excavator reusable :
  • ,
  • Mouth gag non-adjustable :
  • ,
  • Periodontal probe reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental mirror reusable :
  • ,
  • Dental explorer :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Periodontal curette :
  • ,
  • Dental matrix band kit :
  • ,
  • Orthodontic separator :
  • ,
  • Dental power tool handpiece motorless component :
  • ,
  • Pneumatic dental handpiece coupler :
Incipio Devices3650 West 200 North

Huntington IN
46750

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
07/13/202115698
  • Surgical power tool adaptor :
  • ,
  • Acetabular orthopaedic reamer :
Incisive Surgical Inc.95 Corporate Drive

Trumbull
Connecticut 06611

United States

Research Instruments LimitedUK Responsible PersonBickland Industrial Park

Falmouth
Cornwall TR11 4TA
UK Responsible Person
United Kingdom
04/29/202114117
  • Skin stapler/staple bioabsorbable :
Incontinence ShopUnit h lecturers close
Bolton
Bolton
Greater Manchester BL3 6DG

England United Kingdom







11/12/202120107
  • Incontinence pants single-use :
  • ,
  • Draping incontinence liner :
  • ,
  • Incontinence pants reusable :
Increase Benefit Optical Optical Mfy LtdFlat B4. Floor 8 Block B Mai Hing Ind.
16 - 18 Hing Yip Street Kwun Tong
Hong Kong
Kowloon N/A

China

WILLIAM MORRIS LONDON LIMITEDUK Responsible PersonThe Mill Stortford Road Hatfield Heath

Bishop's Stortford
Hertfordshire CM22 7DL
UK Responsible Person
England United Kingdom
03/04/202223394
  • Spectacle frame :
Incus Surgical Ltd22 Bocking End Bocking End

Braintree
Essex CM7 9AA

United Kingdom







10/16/20062895
  • Rigid cystoscope :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Adenoid curette reusable :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Tuning fork :
  • ,
  • Dental mirror reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Head reflector :
  • ,
  • Cilia forceps :
  • ,
  • Dental restoration carver resin :
  • ,
  • Tracheal surgery dilator reusable :
  • ,
  • Nasal septum straightening forceps :
  • ,
  • Nasal endoscope :
  • ,
  • Pleuroscopic/mediastinoscopic trocar blade :
  • ,
  • Myoma screw reusable :
  • ,
  • Enucleation scissors :
  • ,
  • Autopsy hand saw :
  • ,
  • Dental explorer :
  • ,
  • Bone cutting forceps :
  • ,
  • Ear canal irrigation syringe :
  • ,
  • Fistula probe :
  • ,
  • General-purpose syringe reusable :
  • ,
  • Dental curette basic :
  • ,
  • ENT trocar blade :
  • ,
  • Nasal snare reusable :
  • ,
  • Tonsil knife :
  • ,
  • Surgical drill chuck :
  • ,
  • Laryngeal mirror reusable :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Medical tubing clip/clamp temporary non-calibrated reusable :
  • ,
  • Nasal saw :
  • ,
  • Dental anaesthesia syringe cartridge :
  • ,
  • Nail clippers reusable :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Microlaryngeal probe :
  • ,
  • Nasal dilator :
  • ,
  • Periodontal pick/brush reusable :
  • ,
  • Rigid optical laparoscope :
  • ,
  • Percussion hammer manual :
  • ,
  • Surgical gouge :
  • ,
  • Rectal clamp :
  • ,
  • Ring cutter :
  • ,
  • ENT elevator :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Gynaecological scissors reusable :
  • ,
  • Obstetrical forceps reusable :
  • ,
  • Ophthalmic soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Towel clamp reusable :
  • ,
  • Cast breaker :
  • ,
  • Cast cutting scissors :
  • ,
  • Cast cutting shears :
  • ,
  • Cast spreader reusable :
  • ,
  • Cast/plaster knife :
  • ,
  • Ear scissors reusable :
  • ,
  • Eyelid speculum reusable :
  • ,
  • ENT punch :
  • ,
  • ENT probe reusable :
  • ,
  • Endaural surgical curette reusable :
  • ,
  • Bone raspatory :
  • ,
  • Instrument tray reusable :
  • ,
  • Middle ear pick :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • General-purpose bowl reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Nasal scissors :
  • ,
  • Common bile duct dilator :
  • ,
  • Wire holding/twisting forceps :
  • ,
  • Open-surgery biopsy forceps reusable :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Open-surgery stone-retrieval forceps :
  • ,
  • Orthopaedic chisel :
  • ,
  • Rigid endoscopic grasping forceps reusable :
  • ,
  • Surgical instrument containment holder reusable :
  • ,
  • Surgical mallet :
  • ,
  • Uterine elevator :
  • ,
  • Vascular scissors :
  • ,
  • Bone holding forceps :
  • ,
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
  • ,
  • Wire cutter :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • Rigid endoscopic tissue manipulation forceps reusable :
  • ,
  • Rigid endoscopic scissors reusable :
  • ,
  • Nasal file/rasp :
  • ,
  • General-purpose suction system vacuum :
  • ,
  • Haemorrhoid ligator :
  • ,
  • Nasal speculum reusable :
  • ,
  • Skin/tissue hook :
  • ,
  • Skin grafting knife :
  • ,
  • Rectal speculum :
  • ,
  • Ear speculum reusable :
  • ,
  • Cartilage knife :
  • ,
  • Bone curette reusable :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Intrauterine curette manual :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Vein stripper reusable :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Open-surgery dissector :
  • ,
  • Amputation knife :
  • ,
  • Bone hook :
  • ,
  • Brain knife :
  • ,
  • Suturing unit reusable :
  • ,
  • Urethral dilator reusable :
  • ,
  • Vaginal dilator :
  • ,
  • Ear knife :
  • ,
  • Vaginal speculum reusable :
Incydental Ltd74 Eldon Street

Sheffield
South Yorkshire S1 4GT

United Kingdom







04/05/20136793
  • Dental Appliances/Prostheses :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Denture reliner soft professional :
  • ,
  • Denture reliner hard :
  • ,
  • Surgical drill guide obturator :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Bar dental precision attachment :
  • ,
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental cusp permanent :
  • ,
  • Complete lower denture :
  • ,
  • Dental cusp temporary :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental mould :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Mouthguard single-use :
  • ,
  • Complete upper denture :
  • ,
  • Dental veneer professional :
  • ,
  • Denture clasp mould :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture clasp polymer preformed :
  • ,
  • Fluoride gel tray :
  • ,
  • Gold dental inlay :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic clasp metal custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made organ/bone anatomy model :
  • ,
  • Orthodontic teeth positioner preformed :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Dental implant x-ray template :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Surgical implant template reusable :
  • ,
  • Surgical implant template single-use :
  • ,
  • Custom-made organ/bone anatomy model/surgical guide kit :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Bite registration rim :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim wax plate :
  • ,
  • Dental base plate :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
INDIANA OPHTHALMICS LLP135 136 137 Phase-2 GIDC Wadhwancity

Surendranagar
Gujarat 363035

India

CMC Medical Devices LTDUK Responsible PersonOffice 32 19-21 Crawford Street

London
W1H 1PJ
UK Responsible Person
United Kingdom
09/12/202217950
  • Eye lubricant :
  • ,
  • Corneal oedema solution/ointment :
INDIBA S.A.UCarrer del Moianès 13 Poligon Industrial Can Casablancas

Sant Quirze del Valles
Barcelona 08192

Spain

INDIBA UK LTDUK Responsible PersonUnit 67 - Basepoint Business Centre Oakfield Close

Tewkesbury
Gloucestershire GL20 8SD
UK Responsible Person
England United Kingdom
10/27/202118472
  • Radio-frequency skin contouring system applicator monopolar :
  • ,
  • Electrode conductive medium :
  • ,
  • Cupping therapy device :
  • ,
  • Medium-wave diathermy treatment system : Medium-wave diathermy treatment system Conformity Assessment Certificate Expired
  • ,
  • Radio-frequency skin contouring system generator : Radio-frequency skin contouring system generator Conformity Assessment Certificate Expired
  • ,
  • Radio-frequency skin contouring system electrode return : Radio-frequency skin contouring system electrode return Conformity Assessment Certificate Expired
  • ,
  • Radio-frequency skin contouring system applicator monopolar : Radio-frequency skin contouring system applicator monopolar Conformity Assessment Certificate Expired
  • ,
  • Intermittent venous compression system : Intermittent venous compression system Conformity Assessment Certificate Expired
  • ,
  • Cupping therapy device pump : Cupping therapy device pump Conformity Assessment Certificate Expired
Indica Labs8700B Education Place Northwest

Albuquerque
87114

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/17/202221293
  • Histology/cytology/microbiology image-analysis interpretive software IVD :
  • ,
  • Laboratory instrument/analyser application software IVD :
Indus Medicare Private LimitedSuryodaya 1-10-60/3 Begumpet

Hyderabad
Telangana 500016

India

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
11/08/202119917
  • Basic male condom Hevea-latex :
Industria Farmaceutica Galenica Senese S.r.l.Via Cassia Nord 351

Monteroni D'Arbia
Siena 53014

Italy

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/30/202120257
  • Surgical/medical procedure irrigation fluid :
  • ,
  • Surgical/medical procedure irrigation fluid :
Industrial Eyecare Ltd51-55 Eccleston Street St Helens

St. Helens
Merseyside WA10 2PF

United Kingdom







04/06/20223875
  • Spectacle Frames :
  • ,
  • Spectacle Lenses :
Industrial Farmaceutica Cantabria S.A.Arequipa 1

Madrid
28043

Spain

Ferndale Pharmaceuticals LtdUK Responsible PersonUnit 740 Street 2 Thorp Arch Estate

Wetherby
West Yorkshire LS23 7FX
UK Responsible Person
England United Kingdom
info@ferndalepharma.co.uk
04/11/202224125
  • Dry skin moisture barrier dressing :
Industrias Hidraulicas Pardo. S.LCalle Los Angeles 5
Calle Los Angeles 5
La Muela
Aragon 50198

Spain

Innova Care Concepts LtdUK Responsible PersonRofta House Rudgate
Thorp Arch
Wetherby
LS23 7QA
UK Responsible Person
England United Kingdom
02/23/202223187
  • Basic electric hospital bed :
Industrie Biomediche Insubri SAVia Cantonale 67

Mezzovico-Vira
6805

Switzerland

MARKINI GROUP LTD (Trading as Saxon Implantology)UK Responsible Person5 SAXON WAY ALDERHOLT
FORDINGBRIDGE
FORDINGBRIDGE
HANTS SP6 3PH
UK Responsible Person
England United Kingdom
02/03/202214580
  • Bone matrix implant animal-derived bioabsorbable :
  • ,
  • Bone matrix implant animal-derived bioabsorbable :
  • ,
  • Bone matrix implant animal-derived bioabsorbable :
Infermedica Sp. z o.o.Solny Square 14/3

Wroclaw
50-062

Poland

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
10/21/202220796
  • Patient general health self-management software :
Infinite Biomedical Technologies8 Market Pl Suite 500

Baltimore
Maryland 21202

United States

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
07/22/202225101
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Rechargeable battery pack :
  • ,
  • Myoelectric hand prosthesis :
INFINITT Healthcare Co. Ltd.12F Daerung Post Tower 3 27 Digital-ro 34-gil Guro-gu

Seoul
08378

South Korea

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
03/22/202223405
  • Radiology PACS software :
  • ,
  • Radiology PACS software :
  • ,
  • Radiology PACS software :
  • ,
  • Histology/cytology/microbiology image-analysis interpretive software IVD :
Infinity Eyecare Ltd53 St. Helens Gardens

London
W10 6LN

United Kingdom







01/14/20154281
  • Prescription spectacles :
INFOHEALTH LTD61b Stroud Green Road LONDON

London
N4 3EG

United Kingdom

regulatory.affairs@infohealth.co.uk






05/16/20176101
  • Self-care monitoring/reporting software :
INFOMED FLUIDS SRLBlvd. Theodor Pallady no.50 032266 Sector 3

Bucarest
032266

Romania

TRION PHARMA LIMITEDUK Responsible Person26-30 LONDON ROAD

COWPLAIN
HAMPSHIRE PO8 8DL
UK Responsible Person
England United Kingdom
12/10/202120488
  • Urinary catheter/bladder irrigation solution :
Infomed SARoute de compois 11
Route de compois 11
Meinier
1252

Switzerland

LINC Medical Systems LtdUK Responsible Person7 Kingsley Street

Leicester
LE2 6DY
UK Responsible Person
United Kingdom
11/11/202119230
  • Apheresis system :
  • ,
  • Apheresis kit :
  • ,
  • Haemodialysis system dialysate pyrogen-filtration set :
Informatica Systems LtdAurora House Deltic Avenue
Aurora House
Milton Keynes
Buckinghamshire MK13 8LW

England United Kingdom
03303353110






05/31/20176112
  • Standalone Software :
  • ,
  • Clinical management support software :
Infrared Laboratory Systems LLCInfrared Laboratory Systems LLC 17408 Tiller Court
Suite 1900
Westfield
Indiana IN 46074

United States

Woodley Equipment Company LTDUK Responsible PersonOld Station Park Buildings St John St
Horwich
Bolton
Lancashire BL6 7NY
UK Responsible Person
England United Kingdom
12/21/202120690
  • Conjugated (direct) bilirubin IVD reagent :
  • ,
  • Total bilirubin IVD reagent :
Infraredx Inc.34 Third Avenue

Burlington
01803

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/28/202114039
  • Intravascular near-infrared spectroscopy imaging system :
  • ,
  • Intravascular near-infrared spectroscopy imaging system catheter : Intravascular near-infrared spectroscopy imaging system catheter Conformity Assessment Certificate Expired
Infumed GmbHIndustriestraße 45-47a

Friedeburg
26446

Germany

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
10/14/202226476
  • Radiographic procedure tubing :
  • ,
  • Basic intravenous administration set noninvasive :
ING Source LLC1340 14th Avenue Ct SW

Hickory
North Carolina 28602

United States

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL
UK Responsible Person
United Kingdom
08/12/202225499
  • Ankle/foot orthosis :
  • ,
  • Hallux valgus metatarsophalangeal orthosis :
  • ,
  • Compression/pressure sock/stocking reusable :
  • ,
  • Knee support orthosis :
  • ,
  • Multiple-joint arm orthosis :
  • ,
  • Elbow orthosis :
  • ,
  • Compression/pressure glove :
  • ,
  • Therapeutic diabetic sock :
Ingleby house dental practice42 high street

Cullompton
Devon Ex15 1ae

United Kingdom







04/15/202211265
  • Dental appliance fabrication material ceramic :
  • ,
  • Dental appliance fabrication material thermoplastic :
Ingrams Dental Practice187 Greenhill Road

Coalville
LE67 4UF

United Kingdom







01/09/20209486
  • Dental occlusal splint custom-made :
Ing. Carlo Alberto ISSOGLIO & C srlVia F.lli Di Dio

Omegna
68-28887

Italy

Panadent LimitedUK Responsible Person149 sevenoaks way

Orpington
Kent BR5 3AQ
UK Responsible Person
United Kingdom
12/13/202120546
  • Dental anaesthesia syringe intraligamentary :
Inhealthcare LtdCardale House Cardale Court Beckwith Head Road

Harrogate
North Yorkshire HG3 1RY

United Kingdom







04/14/202210076
  • Self-care monitoring/reporting software :
inHEARTIHU Liryc - Hôpital Xavier Arnozan Avenue du Haut Lévêque

Pessac
33600

France

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/07/202117361
  • Image segmentation application software :
  • ,
  • Radiology PACS software :
Inland UK LtdUnit 12 Alma Road Industrial Estate

Chesham
Buckinghamshire HP5 3HB

England United Kingdom







02/28/202223316
  • Prescription spectacles :
InMode Ltd1 Carmel Street Tavor Building
Shaar Yokneam
Yokneam
20692

Israel

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
11/08/202119934
  • Perineal orifice incontinence-control electrical stimulator electrode :
  • ,
  • Radio-frequency skin contouring system applicator tip :
  • ,
  • Multi-modality skin surface treatment system :
  • ,
  • Radio-frequency skin surface treatment system :
  • ,
  • Radio-frequency fat liquefaction system :
  • ,
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
  • ,
  • Radio-frequency skin surface treatment system applicator :
Inmunotek SLAvda. Somosierra 22 Nave 14A San Sebastian de los Reyes

Madrid
28703

Spain

Diagenics LimitedUK Responsible PersonDiagenics Limited Office 2 South House 1 Bond Avenue
Milton Keynes
Milton Keynes
Buckinghamshire MK1 1SW
UK Responsible Person
England United Kingdom
11/25/202225510
  • Nasal irrigation saline solution :
  • ,
  • Nasal irrigation set home-use :
InnaK Diagnostics Inc.6720 Cobra Way Suite L201

San Diego
California 92121

United States

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
06/24/202115434
  • SARS-CoV-2 neutralizing antibody IVD kit enzyme immunoassay (EIA) :
Innersight Labs7 Astbury House Lambeth Road

London
SE11 6LZ

United Kingdom







04/12/20228770
  • Custom-made organ/bone anatomy model :
  • ,
  • Image segmentation application software :
InnFocus Inc.12415 SW 136 Ave Miami FL

Miami
33186

United States

Santen UK LtdUK Responsible PersonSalisbury Hall

St Albans
AL2 1BU
UK Responsible Person
England United Kingdom
04/29/202114078
  • Ophthalmic surgical procedure kit non-medicated single-use :
  • ,
  • Ophthalmic surgical procedure kit non-medicated single-use :
Inno-train Diagnostik GmbHNiederhoechstaedter Str 62

Kronberg
D 61476

Germany

Sussex Biologicals LtdUK Responsible PersonUnit H7/H8 Swallow Enterprise Park
Lower Dicker
Hailsham
East Sussex BN27 4EL
UK Responsible Person
England United Kingdom
04/06/202113153
  • Cell centrifugation/density gradient separation reagent IVD :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory :
  • ,
  • HLA class I & II antigen tissue typing IVD kit complement-dependent cytotoxicity (CDC) :
  • ,
  • HLA class I & II antigen tissue typing IVD control :
  • ,
  • Multiple human platelet antigen (HPA) typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Fluorescent immunoassay analyser IVD laboratory :
  • ,
  • Complement reagent IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • DNA amplification enzyme reagent IVD :
  • ,
  • PCR instrument calibrator kit IVD :
  • ,
  • Protein electrophoresis IVD calibrator :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Human genomic analysis interpretive software IVD :
  • ,
  • Multiple human platelet antigen (HPA) typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Nucleic acid library construction kit IVD :
  • ,
  • Multiple primary immunodeficiency/congenital muscular disorder IVD kit nucleic acid technique (NAT) :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple blood group genotyping IVD primer :
  • ,
  • DNA-based tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple blood group genotyping IVD primer :
Innokas Yhtyma OyVihikari 10

Kempele
90440

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216600
  • Multiple vital physiological parameter monitoring system clinical :
Innolatex (Thailand) LimitedE1-6 Export Processing Zone Southern Industrial Estate Village 4
Chalung Sub-district Hatyai District
Songkhal
90110

Thailand

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
02/10/202220640
  • Basic male condom Hevea-latex :
Innolcon Medical Technology (Suzhou) Co. Ltd.Unit 405/407/409/411 Building B2 No. 218 Xinghu Street Suzhou Industrial Park

Suzhou
Jiangsu 215123

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202216221
  • Soft-tissue ultrasonic surgical system :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece tip single-use :
Innomed Inc.103 Estus Drive

Georgia
Savannah NA

United States

Hospital Innovations LimitedUK Responsible PersonConcept House 1 Heol Y Twyn Talbot Green Business Park

Talbot Green
Rhondda Cynon Taff CF72 9FG
UK Responsible Person
Wales United Kingdom
11/07/202118890
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Cannula clamp :
  • ,
  • Manual bone mill :
  • ,
  • Bone curette reusable :
  • ,
  • Surgical mallet :
  • ,
  • Acetabular orthopaedic reamer :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Bone hook :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical instrument guard reusable :
  • ,
  • Bone approximation clamp :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Arm procedure positioner reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Surgical traction tensioner :
  • ,
  • Leg procedure positioner :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Bone-coring punch reusable :
  • ,
  • Wire/ligature passer reusable :
  • ,
  • Wire holding/twisting pliers :
  • ,
  • Arthroscopic probe :
  • ,
  • Light source adaptor :
  • ,
  • Radiation-shielding procedure preparation glove/mitten :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Wire twister :
  • ,
  • Wire cutter :
  • ,
  • Orthopaedic bone calliper :
  • ,
  • Surgical irrigation/aspiration cannula illuminating reusable :
  • ,
  • Manual goniometer :
  • ,
  • Tape measure reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Head/neck procedure positioner :
  • ,
  • Orthopaedic graft tensioner reusable :
  • ,
  • Orthopaedic fixation implant alignment tool :
  • ,
  • Bone graft funnel :
  • ,
  • Bone holding forceps :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Syringe dispensing gun reusable :
  • ,
  • Skin closure clamp :
  • ,
  • Surgical irrigation/aspiration cannula non-illuminating reusable :
Innosil UK LimitedA7 Stafford Park 15

Telford
Shropshire TF3 3BB

United Kingdom







02/16/20091754
  • Non-Invasive Drainage Devices And Accessories :
Innova Vision Inc.No.231-1 Wen-Te Road

Hsin-Chu County
Chiung-Lin Township 307413

Taiwan

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/01/202118722
  • Soft corrective contact lens daily-disposable :
Innovacon Inc9975 Summer Ridge Road

San Diego
California 92121

United States

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
12/02/202120262
  • Amphetamine/methamphetamine group IVD kit rapid ICT clinical :
  • ,
  • Barbiturate IVD kit rapid ICT clinical :
  • ,
  • Benzodiazepine group IVD kit rapid ICT clinical :
  • ,
  • Cannabinoid/cannabinoid metabolite IVD kit rapid ICT clinical :
  • ,
  • Fentanyl IVD kit rapid ICT clinical :
  • ,
  • Methadone IVD kit rapid ICT clinical :
  • ,
  • Morphine/morphine metabolite IVD kit rapid ICT clinical :
  • ,
  • Phencyclidine (PCP) IVD kit rapid ICT clinical :
  • ,
  • Cocaine/cocaine metabolite IVD kit rapid ICT clinical :
  • ,
  • Propoxyphene/propoxyphene metabolite IVD kit rapid ICT clinical :
  • ,
  • Tramadol IVD kit rapid ICT clinical :
  • ,
  • Cotinine IVD kit rapid ICT clinical :
  • ,
  • Buprenorphine IVD kit rapid ICT clinical :
  • ,
  • Oxycodone IVD kit rapid ICT clinical :
  • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Opiate/opiate metabolite IVD kit rapid ICT clinical :
Innovate Dental Laboratory LimitedLangdale House Vale Drive

Oldham
Lancashire OL9 6TJ

United Kingdom







10/30/20143173
  • Dental Appliances/Prostheses :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Dental implant suprastructure permanent custom-made :
Innovate Orthopaedics LtdThe Globe Bridge Street
Slaithwaite
Huddersfield
HD7 5JN

England United Kingdom







09/05/20166029
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Bone nail guidewire single-use :
Innovation Medical Devices LTD11 Rendlesham Walk

Bedfordshire
Bedfordshire MK41 0AE

England United Kingdom
+447428120152
imedidevices@outlook.com






07/12/202116017
  • Drug-eluting coronary artery stent bioabsorbable-polymer-coated :
  • ,
  • Coronary angioplasty balloon catheter drug-coated :
  • ,
  • Peripheral angioplasty balloon catheter drug-coated :
  • ,
  • Peripheral angioplasty balloon catheter basic :
Innovative Design Orthopaedics Limited6 Brewery Court Theale

Reading
RG 7 5AJ

England United Kingdom







09/17/20136852
  • Total reverse shoulder prosthesis :
  • ,
  • Instrument tray reusable :
  • ,
  • Reverse shoulder prosthesis body :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
Innovative Health Technologies (NZ) LtdLevel 5 229 Moray Place

Dunedin
Select 9016

New Zealand

INNOVATIVE HEALTH TECHNOLOGIES (UK) LIMITEDUK Responsible Person7 Bell Yard

London
WC2A 2JR
UK Responsible Person
England United Kingdom
05/13/202224624
  • Tongue-retaining sleep-disordered breathing orthosis :
Innovative Material and Devices Inc.Building #5 No. 615 Fengdeng Rd. Jia Ding District

Shanghai
201801

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
07/13/202115840
  • Orthodontic archwire :
  • ,
  • Endodontic file retrieval loop :
  • ,
  • Rotary/reciprocating endodontic file/rasp single-use :
  • ,
  • Orthodontic bracket metal :
  • ,
  • Orthodontic metal band :
  • ,
  • Orthodontic tube :
  • ,
  • Orthodontic bracket ceramic :
  • ,
  • Orthodontic aligner auxiliary attachment kit :
Innovative Trauma Care Inc.914 Jordan Cres NW

Edmonton
AB T6L 6X5

Canada

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/01/202118724
  • External haemorrhage clamp :
Innoventa Medica A/SBlokken 45

Birkerod
3460

Denmark

Medical Devices in Healthcare LtdUK Responsible Person36 Peatburn Avenue

Heanor
Derbyshire DE75 7RL
UK Responsible Person
England United Kingdom
09/20/202220809
  • Closed-wound/centesis drainage receptacle :
Innovere Medical Inc.6-250 Shields Court

Markham
Ontario L3R 9W7

Canada

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
03/30/202219085
  • Medical cushion cover :
  • ,
  • Patient audiovisual communication/entertainment system :
  • ,
  • Earplugs single-use :
  • ,
  • Freestanding patient positioner reusable :
  • ,
  • Secondary battery :
INNOVEX MEDICAL CO. LTD.1F and East 2F Building 7 No.150 Cailun Road
Pilot Free Trade Zone
Shanghai
201210

China

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/24/202222098
  • Flexible ureteral sheath/fibreoptic telescope :
  • ,
  • Polymeric ureteral stent :
  • ,
  • Biliary/urinary stone retrieval basket single-use :
  • ,
  • Gastro-urological guidewire single-use :
  • ,
  • Urethral dilatation catheter non-medicated :
Innovo Denture Laboratories Ltd119-121 Grove Lane

Birmingham
B17 0QT

England United Kingdom







02/22/202223180
  • Custom-made mouthguard :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Mouthguard reusable :
Innvol Medical India Limited387 Walajabad Road Kunnam Village
Sriperumbadur Taluk
Kanchipuram District Tamilnadu
631604

India

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/28/202224396
  • Blood washing/centrifugation bag :
Inocer LtdUnit Da2 Sutherland House 43 Sutherland Road

London
E17 6BU

England United Kingdom







05/26/202114978
  • Vision training software :
Inogen Inc.301 Coromar Drive

Goleta
CA 93117

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/29/202224411
  • Mobile/portable oxygen concentrator :
Inotec AMD LTDUnit 7340 Building 7300 Cambridge Research Park
Waterbeach
Cambridge
Cambridgeshire CB259PD

United Kingdom







02/13/20209602
  • Wound therapy oxygenator reusable :
  • ,
  • Wound therapy oxygenator tubing :
  • ,
  • Wound therapy oxygenator reusable : Wound therapy oxygenator reusable Conformity Assessment Certificate Expired
  • ,
  • Rechargeable battery pack : Rechargeable battery pack Conformity Assessment Certificate Expired
INOVA Diagnostics9900 Old Grove Road

San Diego
CA 92131

United States

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202221374
  • Cell morphology analyser IVD manual :
  • ,
  • Smooth muscle antibody IVD control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD calibrator :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD control :
  • ,
  • Beta-2-glycoprotein I antibody IVD control :
  • ,
  • Anticardiolipin antibody IVD control :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD calibrator :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD control :
  • ,
  • Jo-1 antibody IVD calibrator :
  • ,
  • Jo-1 antibody IVD control :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD control :
  • ,
  • Gliadin antibody IVD calibrator :
  • ,
  • Gliadin antibody IVD control :
  • ,
  • Polymyositis-scleroderma antibody (anti-PM-Scl) IVD calibrator :
  • ,
  • Polymyositis-scleroderma antibody (anti-PM-Scl) IVD control :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD calibrator :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD control :
  • ,
  • Rheumatoid factor IVD calibrator :
  • ,
  • Rheumatoid factor IVD control :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD calibrator :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD control :
  • ,
  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD :
  • ,
  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD :
  • ,
  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • SSA/Ro antibody (Sjogren's antibody) IVD calibrator :
  • ,
  • SSA/Ro antibody (Sjogren's antibody) IVD control :
  • ,
  • SSB/La antibody (Sjogren's antibody) IVD calibrator :
  • ,
  • SSB/La antibody (Sjogren's antibody) IVD control :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD calibrator :
  • ,
  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD calibrator :
  • ,
  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD control :
  • ,
  • Smith antibody (anti-Sm) IVD calibrator :
  • ,
  • Smith antibody (anti-Sm) IVD control :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Calprotectin IVD control :
  • ,
  • Complement component C1q IVD kit enzyme immunoassay (EIA) :
  • ,
  • Beta-2-microglobulin IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit multiplex :
  • ,
  • Multiple Coeliac disease-associated antibody IVD kit multiplex :
  • ,
  • Multiple Coeliac disease-associated antibody IVD calibrator :
  • ,
  • Multiple Coeliac disease-associated antibody IVD control :
  • ,
  • Multiple diabetes mellitus-associated antibody IVD reagent :
  • ,
  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adrenal antibody IVD reagent :
  • ,
  • Anticardiolipin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD calibrator :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassay :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD reagent :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD kit fluorescent immunoassay :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD reagent :
  • ,
  • Endomysium antibody (EMA) IVD kit fluorescent immunoassay :
  • ,
  • Endomysium antibody (EMA) IVD control :
  • ,
  • Endomysium antibody (EMA) IVD reagent :
  • ,
  • Gliadin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD calibrator :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD control :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD reagent :
  • ,
  • Intrinsic factor/parietal cell antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Jo-1 antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD control :
  • ,
  • Myelin-associated glycoprotein antibody (anti-MAG) IVD reagent :
  • ,
  • Multiple myocardium antibody IVD reagent :
  • ,
  • Nucleosomal antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassay :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD control :
  • ,
  • Intrinsic factor/parietal cell antibody IVD control :
  • ,
  • Rheumatoid factor IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rheumatoid factor IVD kit chemiluminescent immunoassay :
  • ,
  • Ro52 antibody (anti-Ro52)/Trim21 antibody IVD calibrator :
  • ,
  • Ro52 antibody (anti-Ro52)/Trim21 antibody IVD control :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA) :
  • ,
  • SSA/Ro antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • SSB/La antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Skeletal muscle antibody IVD control :
  • ,
  • Skeletal muscle antibody IVD reagent :
  • ,
  • Sm/RNP antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Sm/RNP antibody IVD calibrator :
  • ,
  • Sm/RNP antibody IVD control :
  • ,
  • Sp-100 protein antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tissue transglutaminase antibody IVD calibrator :
  • ,
  • Tissue transglutaminase antibody IVD control :
  • ,
  • Yo antibody IVD reagent :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory :
  • ,
  • Multiplex analyser IVD laboratory automated :
  • ,
  • Immunohistochemistry conjugated secondary antibody IVD :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Tissue transglutaminase antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Anticardiolipin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD kit chemiluminescent immunoassay :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassay :
  • ,
  • Jo-1 antibody IVD kit chemiluminescent immunoassay :
  • ,
  • SSA/Ro antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Smith antibody (anti-Sm) IVD kit chemiluminescent immunoassay :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit chemiluminescent immunoassay :
  • ,
  • Sm/RNP antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Phosphatidylserine/prothrombin complex antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SSB/La antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassay :
  • ,
  • Ro52antibody(anti-Ro52)/TRIM21antibodyIVD kit chemiluminescent immunoassay :
  • ,
  • RNA polymerase III antibody (anti-Pol III) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Glycoprotein-210 (gp210) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit chemiluminescent immunoassay :
  • ,
  • Ribosomal phosphoprotein antibody IVD kit chemiluminescent immunoassay :
  • ,
  • DoublestrandedDNAantibody (anti-dsDNA) IVD kit chemiluminescent immunoassay :
  • ,
  • Clinical specimen extraction buffer IVD :
  • ,
  • Calprotectin IVD kit chemiluminescent immunoassay :
  • ,
  • 3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD kit fluorescent immunoassay :
  • ,
  • Smooth muscle antibody IVD kit fluorescent immunoassay :
  • ,
  • Smith antibody (anti-Sm) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Intrinsic factor/parietal cell antibody IVD kit fluorescent immunoassay :
  • ,
  • Skin antibody IVD kit fluorescent immunoassay :
  • ,
  • Hu antibody (anti-Hu) IVD reagent :
  • ,
  • Ri antibody (anti-Ri) IVD reagent :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Multiple gastrointestinal disease marker IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cell morphology analyser IVD manual :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory :
  • ,
  • Multiplex analyser IVD laboratory automated :
  • ,
  • Optical instrument performance standard calibrator/control IVD single-use :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Instrument/analyser cleaning agent IVD :
  • ,
  • Multiplex analyser IVD laboratory :
Inovo Inc.401 Leonard Blvd. North Lehigh Acres

Florida
33971

United States

Drive DeVilbiss Healthcare Ltd.UK Responsible PersonSidhil Business Park Holmfield

Halifax
West Yorkshire HX2 9TN
UK Responsible Person
England United Kingdom
07/05/202115701
  • Oxygen therapy conserving regulator :
  • ,
  • Oxygen therapy conserving regulator :
Inpeco SAvia Torraccia 26

Novazzano
6883

Switzerland

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
02/01/202221973
  • Specimen processing instrument IVD :
  • ,
  • Specimen information management system IVD :
InQpharm Consumer Health Ltd.Invision House Wilbury Way Hitchin

Hertfordshire
SG4 0TY

England United Kingdom







11/19/20188232
  • Nasal air filter topical :
Insight Lifetech Co LtdZone E 3rd Floor Building 3 Tinwe Business Park
No 6 Liufang Road
Shenzhen
Baoan District 518000

China

ruddy.shang@insight-med.com
Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202212517
  • Cardiac catheterization laboratory computer :
  • ,
  • Catheter-tip transducer pressure :
Insight Medical Products LtdUnit 3 Priory Industrial Estate

Tetbury
Gloucestershire GL8 8HZ

United Kingdom







05/30/20135469
  • Dressing-fixation skin adhesive tape silicone :
  • ,
  • Tracheostomy tube neck holder reusable :
  • ,
  • Blood pressure transducer holder :
  • ,
  • Tracheostoma protective filter :
  • ,
  • Endotracheal tube holder :
  • ,
  • Medical tubing clip/clamp temporary non-calibrated single-use :
  • ,
  • Intermittent urethral drainage catheter non-antimicrobial reusable :
  • ,
  • Intubation teeth protector :
  • ,
  • Tracheostomy tube cannula cleaning swab non-sterile :
  • ,
  • Eye patch :
  • ,
  • Eye patch sterile :
  • ,
  • Amniotic membrane perforator single-use :
  • ,
  • Tracheostomy tube speech valve :
Insightec Ltd5 Nachum Heth St PO Box 2059

Tirat Carmel
39120

Israel

MedTech Consulting LtdUK Responsible PersonGrafton House Bulls Head Yard

Alcester
Warwickshire B49 5BX
UK Responsible Person
England United Kingdom
06/28/202115614
  • Ultrasonic hyperthermia system :
  • ,
  • Ultrasonic hyperthermia system :
Insignia Medical Systems LtdPaterson House Hatch Warren lane

Basingstoke
Hampshire RG22 4RA

England United Kingdom







01/08/202111441
  • Radiology PACS software :
Inspecs Ltd7-10 Kelso Place Upper Bristol Road

Bath
Avon BA1 3AU

United Kingdom







10/08/20046914
  • Magnifying spectacles :
  • ,
  • Spectacle Frames :
  • ,
  • Spectacle frame :
Inspirata Inc 1 North Dale Mabry Hwy Suite 600 Tampa

Florida
33609

United States

Fujifilm UK LimitedUK Responsible PersonFujifilm House Whitbread Way

Bedford
MK42 0ZE
UK Responsible Person
England United Kingdom
04/12/202221282
  • Microscope slide digital imaging scanner IVD :
Inspiration Healthcare LimitedUnit 2 Satellite Business Village
Fleming Way
CRAWLEY
West Sussex RH10 9NE

United Kingdom







12/02/20199372
  • Infant resuscitation table :
  • ,
  • Electric pad whole-body heating system control unit :
  • ,
  • Electric pad whole-body heating system pad :
  • ,
  • Inspiratory/expiratory limb respiratory tubing reusable :
  • ,
  • Anaesthesia mask strap reusable :
  • ,
  • Inspiratory/expiratory limb respiratory tubing reusable :
  • ,
  • Nasal oxygen cannula CPAP :
  • ,
  • CPAP/BPAP nasal mask single-use :
  • ,
  • Inspiratory/expiratory limb respiratory tubing single-use :
Inspire Medical Systems Inc.5500 Wayzata Blvd. Suite 1600
Golden Valley
Minneapolis
MN 55416

United States

ICON (LR) LimitedUK Responsible PersonConcept House 6 Stoneycroft Rise
Chandlers Ford Eastleigh
Hampshire
SO53 3LD
UK Responsible Person
England United Kingdom
04/08/202113225
  • Implantable sleep apnoea treatment system respiration-sensing :
Inspired Dental Laboratory Ltd16 Belsize Avenue Springfield

Milton Keynes
Buckinghamshire MK6 3LS

United Kingdom







04/09/20226168
  • Dental veneer professional :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Resin dental inlay :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Complete upper denture :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made dental anatomy model :
  • ,
  • Partial denture :
  • ,
  • Bonded dental bridge :
  • ,
  • Complete lower denture :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental impression tray single-use :
  • ,
  • Bite registration rim :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Resin dental inlay :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge polymer :
Inspired Patient Handling Ltd1a Generation House Crab Apple Way
Vale Business Park
Worcestershire
Evesham WR11 1GP

United Kingdom







11/24/202010959
  • General-purpose patient lifting system sling/harness :
Institut Straumann AGPeter Merian-Weg 12

CH-4002 Basel
CH-4002 Basel CH-4002 Basel

Switzerland

Straumann LtdUK Responsible Person10 Finsbury Square

London
EC2A 1AF
UK Responsible Person
England United Kingdom
04/20/202212705
  • Periodontal root surface regeneration material :
  • ,
  • Dental bone matrix implant synthetic :
  • ,
  • Dental root surface conditioner :
  • ,
  • Dental appliance fabrication material ceramic :
  • ,
  • Steel dental bur reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant extractor :
  • ,
  • Dental implant extractor :
  • ,
  • Dental implant extractor :
  • ,
  • Surgical instrument/implant depth limiter :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Dental implant/teeth debridement brush non-biodegradable :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Periodontal root surface regeneration material :
  • ,
  • Crown surgical drill bit reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Crown surgical drill bit single-use :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Dental CAD/CAM system chairside :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental osteotome :
  • ,
  • Dental torque wrench :
  • ,
  • Dental torque wrench :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Dental implant extractor :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Surgical instrument/implant depth limiter :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Bone tap reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental bridge polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental drill bit extension :
  • ,
  • Screw endosteal dental implant one-piece :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Custom-made orthopaedic/craniofacial surgical guide :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental appliance fabrication material ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant internal thread shaping tool :
  • ,
  • Dental implant internal thread shaping tool :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental torque wrench :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated single-use :
  • ,
  • Bone tap reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Surgical implant template reusable :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated single-use :
  • ,
  • Screw endosteal dental implant one-piece :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental implant suprastructure permanent preformed :
Instituto Tecnológico de Canarias S.A.c/ Añepa esquina Tigotán

Agüimes
Gran Canaria 35118

Spain

3D LifePrints UK LtdUK Responsible PersonThe Innovation Hub Alder Hey Children's Hospital Eaton Road
West Derby
Liverpool
Merseyside L12 2AP
UK Responsible Person
England United Kingdom
11/09/202119422
  • Metallic osteotomy fusion cage custom-made :
Instrumentation Laboratory Co180 Hartwell Road

Bedford
01730-2443

United States

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202220572
  • Coagulation analyser IVD laboratory :
  • ,
  • Blood gas/haemoximetry analyser IVD laboratory :
  • ,
  • Multiple blood gas analyte IVD control :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD kit multiple technologies :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD control :
  • ,
  • Multiple electrolyte IVD control :
  • ,
  • Plasma protein IVD control :
  • ,
  • Multiple coagulation factor IVD control :
  • ,
  • Fibrinogen assay (factor I) IVD control :
  • ,
  • Anticardiolipin antibody IVD control :
  • ,
  • Anticardiolipin-B2-glycoprotein I complex antibody IVD control :
  • ,
  • Lupus anticoagulant marker IVD control :
  • ,
  • D-dimer IVD kit agglutination :
  • ,
  • D-dimer IVD control :
  • ,
  • Protein C IVD kit chromogenic :
  • ,
  • Homocysteine IVD kit enzyme spectrophotometry :
  • ,
  • Homocysteine IVD control :
  • ,
  • Anticardiolipin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Anticardiolipin-B2-glycoprotein I complex antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Activated partial thromboplastin time (APTT) IVD kit clotting :
  • ,
  • Prothrombin time (PT) IVD calibrator :
  • ,
  • Prothrombin time (PT) IVD control :
  • ,
  • Thrombin time (TT) IVD kit clotting :
  • ,
  • Multiple coagulation factor IVD calibrator :
  • ,
  • Fibrinogen assay (factor I) IVD kit clotting :
  • ,
  • Coagulation factor II (prothrombin) IVD reagent :
  • ,
  • Coagulation factor V IVD kit clotting :
  • ,
  • Coagulation factor VII IVD kit clotting :
  • ,
  • Coagulation factor VIII IVD kit clotting :
  • ,
  • Coagulation factor VIII IVD kit chromogenic :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor IX IVD kit clotting :
  • ,
  • Coagulation factor XI IVD kit clotting :
  • ,
  • Coagulation factor XII IVD kit clotting :
  • ,
  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD kit nephelometry/turbidimetry :
  • ,
  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD control :
  • ,
  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD reagent :
  • ,
  • Platelet factor 4 IVD control :
  • ,
  • Plasminogen IVD kit chromogenic :
  • ,
  • Coagulation factor Xa inhibitor IVD control :
  • ,
  • Heparin anti-Xa IVD kit chromogenic :
  • ,
  • Heparin anti-Xa IVD calibrator :
  • ,
  • Lupus anticoagulant marker IVD kit clotting :
  • ,
  • Protein S IVD kit clotting :
  • ,
  • Activated protein C resistant factor V (factor V Leiden) IVD kit clotting :
  • ,
  • Alpha-2-antiplasmin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor Xa inhibitor IVD calibrator :
  • ,
  • Heparin anti-Xa IVD control :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Inherited thrombophilia IVD control :
  • ,
  • Coagulation factor XIII A subunit IVD kit nephelometry/turbidimetry :
  • ,
  • Protein S IVD kit nephelometry/turbidimetry :
  • ,
  • Platelet factor 4-heparin complex antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Direct thrombin inhibitor therapeutic drug monitoring IVD calibrator :
  • ,
  • Direct thrombin inhibitor therapeutic drug monitoring IVD control :
  • ,
  • Direct thrombin inhibitor therapeutic drug monitoring IVD kit clotting :
  • ,
  • ADAMTS13 activity IVD kit chemiluminescent immunoassay :
  • ,
  • Prothrombin time (PT) IVD kit clotting :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Buffered wash solution IVD manual :
  • ,
  • Protein C IVD kit clotting :
  • ,
  • Coagulation analyser IVD laboratory :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Instrument/analyser specimen/reagent container carrier IVD :
  • ,
  • Instrument/analyser test tube rack adaptor IVD :
  • ,
  • General laboratory container single-use :
  • ,
  • Buffered wash solution IVD manual :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Laboratory waste receptacle liner IVD :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Antithrombin III (ATIII) IVD kit chromogenic :
  • ,
  • Blood gas/haemoximetry analyser IVD laboratory :
  • ,
  • Barcode reader :
Instrumentation Laboratory SpAViale Monza 338 20128

Milano
20128

Italy

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202220754
  • Uric acid IVD kit enzyme spectrophotometry :
  • ,
  • Urea IVD kit enzyme spectrophotometry :
  • ,
  • Buffered wash solution IVD manual :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Multiple apolipoprotein IVD calibrator :
  • ,
  • Albumin IVD kit spectrophotometry :
  • ,
  • Total protein IVD kit spectrophotometry :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD calibrator :
  • ,
  • Multiple electrolyte IVD calibrator :
  • ,
  • Multiple electrolyte IVD reagent :
  • ,
  • Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometry :
  • ,
  • Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometry :
  • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
  • ,
  • Acetylcholinesterase IVD kit enzyme spectrophotometry :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometry :
  • ,
  • Creatinine IVD kit enzyme spectrophotometry :
  • ,
  • Creatinine IVD kit spectrophotometry :
  • ,
  • Glucose IVD kit enzyme spectrophotometry :
  • ,
  • Total cholesterol lipid IVD kit enzyme spectrophotometry :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometry :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometry :
  • ,
  • Triglyceride IVD kit enzyme spectrophotometry :
Insulet Corporation100 Nagog Park

Massachusetts
01720

United States

Insulet International Limited UK Responsible Person1 King Street 5th Floor

London
W6 9HR
UK Responsible Person
England United Kingdom
10/05/202118002
  • Adhesive bandage :
  • ,
  • Ambulatory insulin infusion pump/blood glucose analyser system :
  • ,
  • Ambulatory insulin infusion pump/blood glucose analyser system :
  • ,
  • Ambulatory insulin infusion pump/blood glucose analyser system :
Int2med ltdSuite 1 Unit A1 Tectonic Place Holyport Road
Berks SL6 2YE
Maidenhead
sl6 2ye

United Kingdom







10/25/20199186
  • Inflatable hot/cold therapy pack/manual pump :
  • ,
  • Inflatable hot/cold therapy pack/manual pump :
Intact Vascular Inc.5905 Nathan Ln N

Plymouth MN
55442

United States

Philips Electronics UK LtdUK Responsible PersonAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW
UK Responsible Person
England United Kingdom
02/25/202223285
  • Peripheral artery stent bare-metal :
Intco Medical (HK) Co LtdFlat/RM 19C Lockhart Centre 301-307 Lockhart Road

Hong Kong
Wan Chai 000000

China
+86 511 831 740 88
liuchangtao@intco.com
Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202218639
  • Wheelchair attendant/occupant-driven rear-wheels-operated collapsible :
  • ,
  • Wheelchair electric-motor-driven attendant/occupant-controlled manual-steering collapsible :
  • ,
  • Handgrip disability-assistive walker non-powered foldable :
  • ,
  • Mobile patient lifting system electrically-powered :
  • ,
  • Hot/cold therapy pack reusable :
  • ,
  • Ice bag :
  • ,
  • Endothermic cold therapy pack :
  • ,
  • Exothermic heat therapy pack/patch :
  • ,
  • Cold/cool therapy gel :
  • ,
  • Assistive scooter electric-motor-driven :
Integra International ASNydalsveien 16a

Oslo
0484

Norway

Innova Care Concepts LtdUK Responsible PersonRofta House Rudgate
Thorp Arch
Wetherby
LS23 7QA
UK Responsible Person
England United Kingdom
12/30/202121508
  • Fixed patient lifting system electrically-powered :
Integra LifeSciences Corporation4900 Charlemar Drive Building A

Cincinnati
Ohio 45227

United States

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
10/15/202218276
  • Stereotactic radiosurgical invasive head frame :
  • ,
  • Skull clamp :
  • ,
  • Medical table clamp :
  • ,
  • Surgical retraction system reusable :
  • ,
  • Neurosurgical retraction system brain :
  • ,
  • Neurological stereotactic surgery system :
  • ,
  • Neurosurgical headrest :
  • ,
  • Skull clamp :
  • ,
  • Medical table clamp :
  • ,
  • Medical table clamp :
Integra LifeSciences Production Corporation_Mansfield11 Cabot Boulevard

Mansfield
MA 02048

United States

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/26/202113748
  • Neurosurgical sponge :
  • ,
  • Lumbar cerebrospinal fluid drainage catheterization kit :
  • ,
  • Ventricular cerebrospinal fluid drainage catheterization kit :
  • ,
  • Intracerebral catheter cranial-fixation kit :
  • ,
  • Cerebrospinal fluid shunt valve :
  • ,
  • Ventriculoperitoneal shunt :
  • ,
  • Subcutaneous tunneller single-use :
  • ,
  • Cerebrospinal fluid shunt connector :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Dura mater biomatrix implant :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar single-use :
  • ,
  • Epidural needle non-threaded :
  • ,
  • Peritoneal/atrial cerebrospinal fluid catheter :
  • ,
  • Cranial port/reservoir :
  • ,
  • Intracerebral infusion/drainage catheter short-term :
  • ,
  • Intracerebral trocar blade :
  • ,
  • Lumboperitoneal shunt :
  • ,
  • Lumbar cerebrospinal fluid drainage catheterization kit :
  • ,
  • Intracerebral cannula nonimplantable reusable :
  • ,
  • Intracranial pressure monitor :
  • ,
  • Ventricular cerebrospinal fluid drainage catheterization kit :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Scalp haemostasis clip reusable :
  • ,
  • Scalp haemostasis clip single-use :
  • ,
  • Cranial trephine single-use :
  • ,
  • Automatic cranial perforator single-use :
  • ,
  • Manual cranial rotary handpiece single-use :
  • ,
  • Craniotomy power tool system pneumatic :
  • ,
  • Subcutaneous tunneller single-use :
  • ,
  • Scalp clip applier single-use :
  • ,
  • Medium-wave diathermy treatment system :
  • ,
  • Cerebrospinal fluid shunt valve :
  • ,
  • Cerebrospinal fluid shunt connector :
  • ,
  • Cerebrospinal fluid shunt valve programmer :
  • ,
  • Surgical irrigation pump :
  • ,
  • Electrosurgical system generator :
  • ,
  • Intracranial pressure monitor :
  • ,
  • Intracranial/compartmental-pressure monitor calibrator/cable :
  • ,
  • Cerebrospinal fluid external drainage kit :
  • ,
  • Foot-switch electrical :
  • ,
  • Frame/rail/pole device holder :
  • ,
  • Cerebrospinal fluid shunt valve programmer :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Subcutaneous tunneller reusable :
  • ,
  • Scalp clip forceps :
  • ,
  • Ventricular cerebrospinal fluid drainage catheterization kit :
  • ,
  • Manual cranial rotary handpiece single-use :
  • ,
  • Electrical-only medical device connection cable single-use :
  • ,
  • Cerebrospinal fluid shunt valve : Cerebrospinal fluid shunt valve Conformity Assessment Certificate Expired
  • ,
  • Atrial cerebrospinal fluid catheter : Atrial cerebrospinal fluid catheter Conformity Assessment Certificate Expired
  • ,
  • Intracerebral infusion/drainage catheter long-term : Intracerebral infusion/drainage catheter long-term Conformity Assessment Certificate Expired
Integra LifeSciences Switzerland SarlRue Girardet 29 (2nd Floor)

Le Locle
Neuchatel CH-2400

Switzerland

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/27/202114010
  • Ventriculoperitoneal shunt :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar single-use :
  • ,
  • Ventriculo-peritoneal/atrial shunt :
  • ,
  • Electrical-only medical device connection cable single-use :
  • ,
  • Intracranial pressure monitor :
  • ,
  • Intracranial/compartmental-pressure monitor calibrator/cable :
  • ,
  • Intracranial pressure monitor :
  • ,
  • Cerebrospinal fluid shunt valve programmer :
Integra LifeSciences (Ireland) Ltd_TullamoreIDA Business & Technology Park Sragh

Tullamore
610

Ireland

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/27/202114011
  • Soft-tissue ultrasonic surgical system handpiece reusable :
  • ,
  • Ultrasonic surgical system adaptor single-use :
  • ,
  • Tissue oxygen monitor :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece tip single-use :
  • ,
  • Surgical irrigation/aspiration tubing set :
  • ,
  • Foot-switch electrical :
  • ,
  • Ultrasonic suction system :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece reusable :
  • ,
  • Soft-tissue ultrasonic surgical system :
  • ,
  • Tissue oxygen monitor :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • General-purpose light source :
  • ,
  • Surgical instrument/endoscope cleaning utensil reusable :
  • ,
  • Transistor tester :
  • ,
  • Electromechanical device/system transport trolley :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Ultrasonic surgical system torque wrench reusable :
  • ,
  • Suction system filter tissue non-sterile :
  • ,
  • Ultrasonic surgical system torque wrench single-use :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece reusable :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece tip reusable :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece tip single-use :
  • ,
  • Ultrasonic surgical system flue :
  • ,
  • Hard-tissue ultrasonic surgical system handpiece tip :
Integra MicroFrance SASLe Pavillion

St Aubin Le Monial
03160

France

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
08/26/202117075
  • Endoscopic electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Endoscopic electrosurgical handpiece/electrode monopolar reusable :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Open-surgery electrosurgical electrode monopolar reusable :
  • ,
  • General-purpose endoscopic needle single-use :
  • ,
  • Ear canal irrigation syringe :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Rigid oesophagoscope :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Frontal sinus file/rasp :
  • ,
  • Rigid laryngopharyngoscope :
  • ,
  • ENT suction dissector :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • ENT transilluminator :
  • ,
  • ENT soft-tissue cutting forceps :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Laryngeal injection kit :
  • ,
  • General-purpose endoscopic needle reusable :
  • ,
  • Endoscope lens cleaner gas/fluid reusable :
  • ,
  • Surgical irrigation/aspiration handpiece reusable :
  • ,
  • ENT examination/treatment system :
  • ,
  • Instrument tray reusable :
  • ,
  • Dissection board :
  • ,
  • ENT wire bending die :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Rigid laryngopharyngoscope :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Paranasal sinus guidewire :
  • ,
  • Skin marking guide reusable :
  • ,
  • Nasal snare reusable :
  • ,
  • Surgical mallet :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Ear speculum reusable :
  • ,
  • ENT speculum holder :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Temporal bone holder :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Rectal suction biopsy system :
  • ,
  • ENT cartilage cutter :
  • ,
  • Luer/non-ISO80369-standardized linear connector reusable :
  • ,
  • Scalpel handle reusable :
  • ,
  • Ear knife :
  • ,
  • Middle ear pick :
  • ,
  • Plastic surgery file/rasp :
  • ,
  • Bone awl reusable :
  • ,
  • Middle ear chisel :
  • ,
  • Surgical tamp reusable :
  • ,
  • Tympanostomy tube inserter reusable :
  • ,
  • Ear scissors reusable :
  • ,
  • ENT probe reusable :
  • ,
  • Towel clamp reusable :
  • ,
  • Middle ear malleus nipper :
  • ,
  • Paranasal sinus probe :
  • ,
  • Middle ear file/rasp :
  • ,
  • Nasal file/rasp :
  • ,
  • Ear excavator :
  • ,
  • ENT soft-tissue cutting forceps :
  • ,
  • Nasal knife :
  • ,
  • Laryngeal knife :
  • ,
  • Flexible endoscopic biopsy forceps reusable :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Endaural surgical curette reusable :
  • ,
  • Paranasal sinus curette :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Paranasal sinus guidewire :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Skin marking guide reusable :
  • ,
  • General-purpose absorbent tip applicator/swab reusable :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Adenotome :
  • ,
  • Open-surgery dissector :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Plastic surgery osteotome :
  • ,
  • Tonsil snare :
  • ,
  • Tongue depressor surgical :
  • ,
  • Tonsillectome :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Ear speculum reusable :
  • ,
  • Craniofacial rongeur reusable :
  • ,
  • ENT elevator :
  • ,
  • Rigid endoscopic tissue manipulation forceps reusable :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Scalpel reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Rhinoscopic mirror :
  • ,
  • General-purpose surgical spatula :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Externally-anchored laparoscopic retractor :
Integra Neurosciences Implants (France) SAS_Sophia Antipolis2905 Route des Dolines

Sophia Antipolis
06921

France

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/26/202113745
  • Cranial port/reservoir :
  • ,
  • Intracerebral infusion/drainage catheter long-term :
  • ,
  • Lumboperitoneal shunt :
  • ,
  • Lumboperitoneal shunt spinal catheter :
  • ,
  • Cortical electrode :
  • ,
  • Depth electrode :
  • ,
  • Spinal needle single-use :
  • ,
  • Neurosurgical procedure kit non-medicated single-use :
  • ,
  • Neural-tissue balloon catheter :
  • ,
  • Cerebrospinal fluid shunt connector :
  • ,
  • Intracranial catheter holder :
  • ,
  • Ventriculo-peritoneal/atrial shunt :
  • ,
  • Peritoneal/atrial cerebrospinal fluid catheter :
  • ,
  • Intracerebral sensor catheter short-term :
  • ,
  • Intracerebral infusion/drainage catheter short-term :
  • ,
  • Cerebrospinal fluid external drainage kit :
  • ,
  • Lumbar cerebrospinal fluid drainage catheterization kit :
  • ,
  • Ventricular cerebrospinal fluid drainage catheterization kit :
  • ,
  • Intracranial catheter holder :
  • ,
  • Subcutaneous tunneller single-use :
  • ,
  • General-purpose patient temperature probe single-use :
  • ,
  • Subcutaneous tunneller reusable :
  • ,
  • Luer/Luer linear connector single-use :
  • ,
  • Cerebrospinal fluid external drainage kit :
  • ,
  • Sensor holder single-use :
Integra Neurosciences LimitedKingsgate House Newbury Road

Andover
Hampshire SP10 4DU

England United Kingdom







07/19/20062997
  • misc 20081126 :
Integra Neurosciences_Princeton1100 Campus Road

Princeton
08540

United States

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/27/202114013
  • Nerve guide bioabsorbable animal-derived :
  • ,
  • Collagen wound matrix dressing :
  • ,
  • Wound protein matrix solution :
  • ,
  • Dura mater sealant :
  • ,
  • Collagen haemostatic agent non-antimicrobial :
  • ,
  • Dura mater graft bovine :
  • ,
  • Cerebrospinal fluid shunt valve/port/reservoir :
  • ,
  • Cerebrospinal fluid shunt valve :
  • ,
  • Cerebrospinal fluid shunt valve programmer :
  • ,
  • Ventriculoperitoneal shunt :
  • ,
  • Subcutaneous tunneller single-use :
  • ,
  • Carotid artery shunt :
  • ,
  • Cerebrospinal fluid shunt connector :
  • ,
  • Atrial cerebrospinal fluid catheter :
  • ,
  • Peritoneal/atrial cerebrospinal fluid catheter :
  • ,
  • Intracerebral infusion/drainage catheter long-term :
  • ,
  • Intracerebral infusion/drainage catheter short-term :
  • ,
  • Lumboperitoneal shunt :
  • ,
  • Lumbar cerebrospinal fluid drainage catheterization kit :
  • ,
  • Open-surgery adhesive/sealant applicator dual-channel :
  • ,
  • Non-fixed medical gas cylinder regulator :
  • ,
  • Dental soft-tissue matrix implant animal-derived :
  • ,
  • Frame/rail/pole device holder :
  • ,
  • Ventriculoperitoneal shunt :
  • ,
  • Ventricular cerebrospinal fluid drainage catheterization kit :
  • ,
  • General oral wound dressing animal-derived : General oral wound dressing animal-derived Conformity Assessment Certificate Expired
Integra Pain Management_West Valley City3498 West 2400 South Suite 1050

West Valley City
84119

United States

Integra Neurosciences LimitedUK Responsible PersonKingsgate House Newbury Road

Andover
Hampshire SP10 4DU
UK Responsible Person
England United Kingdom
04/27/202114007
  • Manual cranial rotary handpiece single-use :
Integral Medical Products Co. Ltd.No.2 Dongze Road High-Tech Industrial Development Zone

Shaoxing
Zhejiang 312000

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202215839
  • Anaesthesia face mask single-use :
  • ,
  • Laryngeal airway introducer :
  • ,
  • Urine-sampling urethral catheter :
  • ,
  • Laryngeal mask airway single-use :
  • ,
  • Laryngeal mask airway reusable :
Integrated Endoscopy Inc.16
Technology Dr Irvine
Orange
CA 92618

United States

Hospital Innovations LimitedUK Responsible PersonConcept House 1 Heol Y Twyn Talbot Green Business Park

Talbot Green
Rhondda Cynon Taff CF72 9FG
UK Responsible Person
Wales United Kingdom
04/29/202113962
  • Rigid arthroscope reusable :
Integrated Lens Technology PTE Ltd.201 Kallang Bahru #02-01 Essilor Building I

Singapore
339338

Singapore

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
11/05/202118732
  • Pre-prescription spectacle lens :
Integration Diagnostics Sweden ABFürstenbergsgatan 4
Göteborg
Göteborg
Västra Götalands Län 416 64

Sweden

NSK United Kingdom LimitedUK Responsible PersonOffice 4 Gateway 1000 Arlington Business Park
Whittle Way Stevenage
Stevenage
Hertfordshire SG1 2FP
UK Responsible Person
England United Kingdom
04/25/202219325
  • Multimeter :
Integrity Implants Inc.354 Hiatt Drive

Palm Beach Gardens FL
33418

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
06/08/202115083
  • Polymeric spinal interbody fusion cage :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Open-surgery dissector :
  • ,
  • Scalpel handle reusable :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Bone curette reusable :
  • ,
  • Surgical mallet :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical tamp reusable :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Spinal rongeur :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Endoscopic-access dilator reusable :
  • ,
  • Spinal implant trial :
  • ,
  • Orthopaedic graft guide :
  • ,
  • Orthopaedic implantation hammering attachment :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical instrument handle torque-limiting :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Orthopaedic feeler :
  • ,
  • Bone graft funnel :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Arthroscopic obturator :
  • ,
  • Instrument tray reusable :
Intelerad Medical Systems Incorporated800 Boul. de Maisonneuve E 12th floor Montreal

Montreal
Quebec H2L 4L8

Canada

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/01/202222007
  • Radiology PACS software :
Intelex Group (UK) LimitedUnit 17-18 Regent Park 37 Booth Drive Park Farm Industrial Estate

Wellingborough
Northamptonshire NN8 6GR

United Kingdom







04/09/20225934
  • Hot/cold therapy pack reusable :
Intelligent Dental Solutions Laboratory LtdUnit 317 Jarrow Business Centre Rolling Mill Road Viking Industrial Estate

Jarrow
NE32 3DT

United Kingdom







08/21/20123155
  • Complete lower denture :
  • ,
  • Partial denture :
  • ,
  • Overdenture :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Complete upper denture :
Intelligent Endoscopy LLC4740 Commercial Park Court Suite 1

Clemmons
North Carolina/Forsyth 27012

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/26/202118549
  • Oesophageal endoscopic ligator single-use :
Intelligent System Co. Ltd.4316-1 Johana Nanto

Toyama
939-1865

Japan

Sense Medical Limited UK Responsible Person3 Mulberry Court 59C London Road

Bagshot
Surrey GU19 5DT
UK Responsible Person
Wales United Kingdom
05/27/202224783
  • Psychophysiological biofeedback system :
Intelligent Ultrasound LimitedFloor 6A Hodge House 114-116 St. Mary Street

Cardiff
Glamorgan CF10 1DY

Wales United Kingdom







10/26/20175727
  • Ultrasound imaging system application software :
Intensiv Medical Products IMPROMEDIFORM GmbHGielster Stück 11

Lüdenscheid
58513

Germany

Medical Device Management LtdUK Responsible Person31 Braintree Business Park Blackwell Drive

Braintree
Essex CM7 2PU
UK Responsible Person
England United Kingdom
01/07/202221834
  • Electric infusion pump administration set single-use :
  • ,
  • Blood transfer set :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Intravenous administration bag/bottle :
Inter-Med Inc.2200 South St

Racine
Wisconsin 53404

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/27/202118477
  • Dentine bonding agent/set :
  • ,
  • Dental material application tool single-use :
  • ,
  • Dental etching solution :
  • ,
  • Root canal cleaning solution :
  • ,
  • Gingival retraction solution :
  • ,
  • Dental material injection cannula single-use :
  • ,
  • Dental prosthesis priming agent :
  • ,
  • Root canal irrigation blunt needle :
  • ,
  • Medical equipment handle cover single-use non-sterile :
  • ,
  • Dental delivery system irrigation handpiece :
  • ,
  • Dental material heater :
  • ,
  • Dental material heater :
  • ,
  • Dental/surgical polymerization lamp :
Interacoustics A/SAudiometer Allé

Middelfart
DK 5500

Denmark

Oticon LimitedUK Responsible PersonCadzow Industrial Estate

Hamilton
Lanarkshire ML3 7QE
UK Responsible Person
United Kingdom
08/11/202116631
  • Electronystagmograph :
  • ,
  • Otoscope direct :
  • ,
  • Vestibulo-ocular function chair :
  • ,
  • Diagnostic caloric vestibular stimulation system :
  • ,
  • Audiometric/hearing aid tester :
  • ,
  • Dynamic visual acuity testing system :
  • ,
  • Canalith repositioning procedure chair manual :
  • ,
  • Vestibulo-auditory analysis system :
  • ,
  • Vision physiology/eye movement analysis system :
  • ,
  • Vision physiology/eye movement analysis system :
INTERDENT d.o.o.Opekarniska cesta 26

Celje
3000

Slovenia

Panadent LimitedUK Responsible Person149 sevenoaks way

Orpington
Kent BR5 3AQ
UK Responsible Person
United Kingdom
03/31/202223980
  • Dental mould :
  • ,
  • Dental matrix band single-use :
  • ,
  • Dental articulation paper :
  • ,
  • Dental articulation paste/solution :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental mirror reusable :
  • ,
  • Saliva absorbent :
  • ,
  • Wax dental impression material :
  • ,
  • Dental base plate :
  • ,
  • Bite registration rim wax :
  • ,
  • Dental wedge single-use :
  • ,
  • Dental anchor :
  • ,
  • Dental appliance fabrication material ceramic :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Dental casting non-noble alloy :
  • ,
  • Dental suction system cannula single-use :
  • ,
  • Dental wrought alloy :
  • ,
  • Root canal post preformed :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental appliance fabrication material thermoplastic :
  • ,
  • Dental appliance fabrication material combination-material :
Intermark Medical innovations LtdThe Coach House 34 Southborough Road

Bromley
Kent BR1 2EB

England United Kingdom

INTERMARK MEDICAL (NI) LTDAuthorised Representative (Northern Ireland)8th Floor Centrepoint 24 Ormeau Avenue

Belfast
BT2 8HS
Authorised Representative (Northern Ireland)
Northern Ireland United Kingdom
02/16/202212161
  • Rectal irrigation kit :
  • ,
  • Colonic lavage kit surgical :
Intermark Medical Innovations LtdThe Coach House 34 Southborough Road

Bromley
Kent BR1 2EB

United Kingdom







01/23/20133703
  • Rectal irrigation kit :
  • ,
  • Colonic lavage kit surgical :
  • ,
  • Surgical instrument assist arm system manually-adjusted :
INTERMED EQUIPAMENTO MÉDICO HOSPITALAR LTDARua Santa Mônica 980

Cotia
06715-865

Brazil

Vyaire Medical Products LimitedUK Responsible PersonChineham Gate Chineham Business Park Crockford Lane

Basingstoke
RG24 8NA
UK Responsible Person
England United Kingdom
09/17/202117668
  • Breathing circuit gas-flow sensor reusable :
  • ,
  • Anaesthesia breathing circuit reusable :
  • ,
  • Breathing circuit tube holder :
  • ,
  • Neonatal/adult intensive-care ventilator :
  • ,
  • Utility trolley :
  • ,
  • Straight/elbow breathing circuit connector reusable :
INTERMEDIC ARFRAN S.A.calle Ocaña numero 59 Local bajo 1

MADRID
28047

Spain

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
05/11/202224580
  • General/multiple surgical diode laser system :
INTERMEDT Medizin & Technik GmbHGewerbestraße-Süd 13

Ostrhauderfehn
26842

Germany

B. Braun Medical LtdUK Responsible PersonBrookdale Road Chapeltown

Sheffield
South Yorkshire S35 2PW
UK Responsible Person
United Kingdom
09/22/202117698
  • Haemodialysis system fluid mixer :
  • ,
  • Haemodialysis concentrate :
INTERNATIONAL DENTAL SUPPLYSTREET# 5 HARRAR RORAS ROAD

SIALKOT
PUNJAB 51310

Pakistan

Certirep UK LimitedUK Responsible Person19 Abbotts Crescent

LONDON
E4 9SA
UK Responsible Person
England United Kingdom
03/22/202223754
  • Mastoid gouge :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Dental mirror reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Paraffin wax knife :
  • ,
  • Dental wax carver :
  • ,
  • Hand-held dental retractor :
  • ,
  • Scalpel handle reusable :
  • ,
  • Rubber dam kit :
  • ,
  • Rubber dam clamp :
  • ,
  • Periodontal probe reusable :
  • ,
  • Towel clamp reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Dental matrix band retainer :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental explorer :
  • ,
  • Dental excavator reusable :
  • ,
  • Dental anaesthesia syringe cartridge :
  • ,
  • Orthodontic pliers :
  • ,
  • Dental x-ray film holder reusable :
  • ,
  • Dental spatula reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Dental restoration carver amalgam reusable :
  • ,
  • Dental amalgam carrier :
International Eyewear Ltd27 Blackberry Lane

Halesowen
West Midlands B63 4NX

United Kingdom







08/25/993365
  • Spectacle frame :
International Glazing Services LtdUnit 1 Vale Industrial Estate Kidderminster

Worcestershire
DY11 7QU

United Kingdom







12/14/20122597
  • Spectacle Lenses :
  • ,
  • Spectacle Frames :
  • ,
  • Prescribed Spectacles :
International Life Sciences2252 Northwest Pkwy SE Suite G

MARIETTA
30067

United States

Templar Regulatory Consulting Limited UK Responsible PersonNiall House Unit 4 24-26 Boulton Road
Stevenage
Stevenage
Hertfordshire SG14QX
UK Responsible Person
England United Kingdom
05/04/202114392
  • Extra-gynaecological surgical mesh synthetic polymer bioabsorbable :
Interneuron CIC2 River Lane Haslingfield

Cambridge
Cambridgeshire CB23 1LX

United Kingdom







04/15/202210631
  • Clinical management support software :
Interpod Pty Ltd115A Church St

Brighton
VIC 3186

Australia

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/05/202213095
  • Orthotic insole prefabricated non-antimicrobial :
Interrad Medical Inc.181 Cheshire Lane N Suite 100

Plymouth MN
55441

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
03/17/202213538
  • Wearable percutaneous catheter/tube holder :
INTERSCOPE INC200 COMMERCE DRIVE

NORTHBRIGE
MASSACHUSETTS 1534

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/24/202224719
  • Tissue morcellation system control unit :
  • ,
  • Tissue morcellation system handpiece line-powered :
  • ,
  • Surgical suction system Y-piece valve-connector :
  • ,
  • Surgical suction system collection container single-use :
Intersect ENT GmbHNeuendorfstr. 23b

Hennigsdorf
Brandenburg 16761

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
05/03/202224469
  • Multi-purpose stereotactic surgery system :
  • ,
  • Multi-purpose stereotactic surgery system :
Intersect ENT1555 Adams Drive

Menlo Park
California 94025

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
06/18/202115350
  • Drug-eluting paranasal sinus stent : Drug-eluting paranasal sinus stent Conformity Assessment Certificate Expired
  • ,
  • Drug-eluting paranasal sinus stent :
Intersurgical LtdCrane House Molly Millars Lane

Wokingham
Berkshire RG41 2RZ

England United Kingdom







11/26/20199283
  • Pulmonary function testing kit :
  • ,
  • Nose clip single-use :
  • ,
  • Positive pressure airway secretion-clearing device :
  • ,
  • Endoscope patient protection cap single-use :
  • ,
  • Medical device service rail clamp :
  • ,
  • Frame/rail/pole device holder :
  • ,
  • Oxygen administration enhancement device :
  • ,
  • Laryngoscope handle reusable :
  • ,
  • Laryngoscope blade single-use :
  • ,
  • Video intubation laryngoscope kit :
  • ,
  • Rigid intubation laryngoscope single-use :
  • ,
  • Basic manual toothbrush :
  • ,
  • Infant head cap :
  • ,
  • Surgical/medical face mask non-antimicrobial single-use :
  • ,
  • Breathing circuit catheter mount reusable :
  • ,
  • CPAP/BPAP face mask single-use :
  • ,
  • CPAP/BPAP face mask single-use :
  • ,
  • Basic endotracheal tube single-use :
  • ,
  • Oxygen administration enhancement device :
  • ,
  • PEEP valve single-use :
  • ,
  • Carbon dioxide cuvette single-use :
  • ,
  • Heat/moisture exchanger/microbial medical gas filter :
  • ,
  • Reinforced endotracheal tube single-use :
  • ,
  • Anaesthesia face mask single-use :
  • ,
  • Gas-sampling/monitoring respiratory tubing single-use :
  • ,
  • Oral care kit single-use :
  • ,
  • Laryngeal mask airway single-use :
  • ,
  • Breathing mouthpiece single-use :
  • ,
  • Y-piece breathing circuit connector reusable :
  • ,
  • Breathing circuit catheter mount single-use :
  • ,
  • Artificial airway stylet single-use :
  • ,
  • Reinforced laryngeal mask airway single-use :
  • ,
  • CPAP/BPAP unit ambient air filter single-use :
  • ,
  • Breathing circuit condenser cartridge :
  • ,
  • Breathing circuit condenser :
  • ,
  • Tube/mask breathing circuit connector single-use sterile :
  • ,
  • Straight/elbow breathing circuit connector single-use :
  • ,
  • Heat/moisture exchanger/microbial filter sterile :
  • ,
  • Pulmonary function testing filter/mouthpiece :
  • ,
  • Microbial medical gas filter sterile single-use :
  • ,
  • Inspiratory line humidification chamber single-use :
  • ,
  • Resuscitator face mask single-use :
  • ,
  • Incentive spirometer :
  • ,
  • Y-piece breathing circuit connector single-use :
  • ,
  • Straight/elbow breathing circuit connector reusable :
  • ,
  • Oropharyngeal airway single-use :
  • ,
  • Tracheostomy mask aerosol :
  • ,
  • Non-rebreathing valve reusable :
  • ,
  • Nasal oxygen cannula basic :
  • ,
  • Anaesthesia face mask reusable :
  • ,
  • Venturi oxygen face mask :
  • ,
  • Non-rebreathing oxygen face mask :
  • ,
  • Non-heated respiratory humidifier :
  • ,
  • Rebreathing oxygen face mask :
  • ,
  • Aerosol face mask rebreathing single-use :
  • ,
  • Breathing circuit bag single-use :
  • ,
  • Breathing circuit condensate trap reusable :
  • ,
  • Pressure relief valve single-use :
  • ,
  • Nebulizing system delivery set single-use :
  • ,
  • Oxygen administration tubing :
  • ,
  • Benchtop nebulizer non-heated :
  • ,
  • Heat/moisture exchanger single-use :
  • ,
  • Carbon dioxide absorber single-use :
  • ,
  • Endotracheal tube introducer single-use :
  • ,
  • Breathing circuit condensate trap single-use :
  • ,
  • CPAP/BPAP nasal mask reusable :
  • ,
  • Breathing circuit bag reusable :
  • ,
  • Invasive medical device leak tester electrical :
  • ,
  • Nasal oxygen cannula carbon-dioxide-sampling :
  • ,
  • Pulmonary resuscitator manual single-use :
  • ,
  • Cardiopulmonary resuscitation mask reusable :
  • ,
  • Carbon dioxide absorbent :
  • ,
  • Airway suction catheter :
  • ,
  • Anaesthesia breathing circuit reusable :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Ventilator breathing circuit reusable :
  • ,
  • Ventilator breathing circuit single-use :
  • ,
  • Pulmonary function testing kit :
  • ,
  • Microbial medical gas filter single-use :
  • ,
  • Endoscopic bite block oxygenating :
  • ,
  • Neonatal high-flow respiratory unit :
Intersurgical SpAVia Morandi 12

Mirandola
41037

Italy

Intersurgical LtdUK Responsible PersonCrane House Molly Millars Lane

Wokingham
Berkshire RG41 2RZ
UK Responsible Person
England United Kingdom
11/23/202120192
  • Oxygen administration tent adult :
  • ,
  • PEEP valve reusable :
  • ,
  • Venturi oxygen face mask :
  • ,
  • Straight/elbow breathing circuit connector single-use :
  • ,
  • Straight/elbow breathing circuit connector single-use :
InterSystemsInterSystems House Tangier Lane Eton

Windsor
Berkshire SL4 6BB

England United Kingdom







06/22/202225056
  • Clinical management support software :
Interton A/SLautrupbjerg 7

Ballerup
DK-2750

Denmark

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
02/01/202221855
  • Air-conduction hearing aid behind-the-ear :
  • ,
  • Air-conduction hearing aid in-the-ear :
  • ,
  • Air-conduction hearing aid canal :
  • ,
  • Air-conduction hearing aid receiver-in-canal :
  • ,
  • Audiometric/hearing device software :
  • ,
  • Hearing aid/implant system remote control :
Intervascular SASZI Athélia I 13705
CEDEX
LA CIOTAT
13705

France

Getinge Ltd.UK Responsible Person14-15 Burford Way Boldon Business Park
Boldon Colliery Tyne and Wear
Boldon
NE35 9PZ
UK Responsible Person
England United Kingdom
04/14/202113358
  • Open-surgery vascular sizer single-use :
  • ,
  • Synthetic vascular graft :
  • ,
  • Cardiovascular patch animal-derived :
Interweave Textiles LtdBirkby Grange Birkby Hall Road
Birkby Grange
Huddersfield
Yorkshire HD2 2XB

England United Kingdom
01422372333
sales@interweavetextiles.com






07/06/20224117
  • Hospital Beds And Patient Positioning Aids :
  • ,
  • Patient Hoists/ Transfer Aids And Accessories :
  • ,
  • Warming And Cooling Pads And Blankets (Non-Active And Non-Chemical) :
  • ,
  • Allergen Resistant Bedding :
  • ,
  • Incision Drapes/Theatre Clothing :
  • ,
  • Instrument Cleaning Solutions/Wipes (Non-Disinfecting) :
  • ,
  • Surgical Equipment Sterile Drapes :
  • ,
  • Rescue blanket reusable :
Intigena GmbH & Co.KGSteineshoffweg 2

Mülheim a. d. Ruhr
45479

Germany

Regulis Consulting LimitedUK Responsible PersonWessex House Marlow Road

Bourne End
Buckinghamshire SL8 5SP
UK Responsible Person
England United Kingdom
12/10/202120450
  • Incontinence pants single-use :
  • ,
  • Incontinence pants liner :
Intocare Medical Technology203# Building NW-12 Nanopolis Suzhou
No. 99 Jinji Lake Ave Suzhou Industrial Park
Suzhou
Suzhou 215001

China

CJ MedicalUK Responsible PersonCharles House Threemilestone

Truro
TR49FB
UK Responsible Person
England United Kingdom
fiona@cjmedical.com
09/06/202225794
  • Endoscopic motorized cutting stapler single-use :
  • ,
  • Intraluminal circular stapler single-use :
  • ,
  • Motorized cutting stapler handpiece :
InTouch with HealthUnit 3 Querns Business Centre Whitworth Road

CIRENCESTER
Gloucestershire GL7 1RT

United Kingdom







02/10/20155175
  • Clinical information system web-based application software :
  • ,
  • Standalone Software :
intra special catheters GmbHOststraße 2

Rehlingen-Siersburg
66780

Germany

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
04/26/202215209
  • Arterial/central venous catheterization support/maintenance kit non-medicated :
Intracell Medical UK LimitedLeonard House First Floor 5 - 7 Newman Road

Bromley
Kent BR1 1RJ

England United Kingdom







04/30/202214135
  • Polyester suture bioabsorbable monofilament non-antimicrobial :
Intrapharm Laboratories LtdChoke Lane

Maidenhead
Berkshire SL6 6PT

England United Kingdom







04/08/20225335
  • Aquamax skin cream :
  • ,
  • Aquamax body wash :
IntroMedic Co. Ltd.Suite 1105 1106 41 Digital-ro 31-gil Guro-gu

Seoul
08375

South Korea

CMC Medical Devices LTDUK Responsible PersonOffice 32 19-21 Crawford Street

London
W1H 1PJ
UK Responsible Person
United Kingdom
07/07/202225201
  • Video capsule endoscopy system capsule :
  • ,
  • Video capsule endoscopy system capsule :
Intuitive Surgical Inc1266 Kifer Rd

Sunnyvale
California CA 94086

United States

Intuitive Surgical LtdUK Responsible PersonThe Schrodinger Building Oxford Science Park
Heatley Rd
Oxford
Oxfordshire OX4 4GE
UK Responsible Person
England United Kingdom
04/15/202113464
  • Rigid endoscope working guide :
  • ,
  • Endoscope video camera :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Surgical camera holder :
  • ,
  • Instrument tray reusable :
  • ,
  • Surgical instrument guard reusable :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Robotic surgical system :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Surgical instrument/endoscope cleaning utensil reusable :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Instrument tray reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrosurgical system generator :
  • ,
  • Electrosurgical system monitor/shield :
  • ,
  • Endoscopic electrosurgical electrode monopolar single-use :
  • ,
  • Laparoscopic access cannula seal reducer :
  • ,
  • Rigid optical laparoscope :
  • ,
  • Robotic electrosurgical instrument monopolar reusable :
  • ,
  • Laparoscopic access cannula reusable :
  • ,
  • Robotic surgical forceps reusable :
  • ,
  • Robotic electrosurgical instrument bipolar single-use :
  • ,
  • Laparoscopic motorized instrument control unit :
  • ,
  • Rigid endoscopic scissors reusable :
  • ,
  • Manual scalpel blade single-use :
  • ,
  • Robotic surgical irrigation/aspiration cannula reusable :
  • ,
  • Robotic surgical cutting stapler single-use :
  • ,
  • Robotic surgical cutting stapler reusable :
  • ,
  • Laparoscopic trocar blade single-use :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Laparoscopic access cannula seal single-use :
  • ,
  • Optical medical device procedural cover :
  • ,
  • Laparoscopic multi-instrument access port single-use :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Robotic electrosurgical instrument bipolar reusable :
  • ,
  • Robotic surgical retractor :
  • ,
  • Robotic surgical ligation clip applier :
  • ,
  • Robotic surgical irrigation/aspiration cannula single-use :
  • ,
  • Robotic surgical needle holder reusable :
  • ,
  • Robotic surgical system :
  • ,
  • Soft-tissue ultrasonic robotic surgical instrument single-use :
  • ,
  • Robotic surgical scissors :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece reusable :
  • ,
  • Soft-tissue ultrasonic surgical system handpiece tip single-use :
  • ,
  • Medical equipment drape single-use :
  • ,
  • Laparoscopic access cannula seal single-use :
  • ,
  • Laparoscopic access cannula seal single-use :
  • ,
  • Surgical staple loading unit cutting :
Inuvi Diagnostics LimitedUnit 10 Millars Brook Business Park
Molly Millars Lane
Wokingham
RG41 2AD

England United Kingdom







07/14/202225326
  • Capillary blood collection system IVD :
Invacare CorporationOne Invacare Way

Elyria OHIO
44035

United States

INVACARE UK OPERATIONS LIMITEDUK Responsible PersonUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ
UK Responsible Person
United Kingdom
07/23/202115780
  • Mobile/portable oxygen concentrator :
  • ,
  • Stationary oxygen concentrator :
  • ,
  • Oxygen refillable cylinder :
Invacare France Operations SASInvacare France Operations SAS Route de Saint Roch

Fondettes
37230

France

INVACARE UK OPERATIONS LIMITEDUK Responsible PersonUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ
UK Responsible Person
United Kingdom
06/28/202115536
  • Wheelchair attendant/occupant-driven bimanual-lever-operated collapsible :
  • ,
  • Wheelchair occupant-driven bimanual-lever-operated non-collapsible :
  • ,
  • Wheelchair electric-motor-driven attendant/occupant-controlled powered-steering collapsible :
Invacare GmbHAm Achener Hof 8

Isny
88316

Germany

INVACARE UK OPERATIONS LIMITEDUK Responsible PersonUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ
UK Responsible Person
United Kingdom
06/25/202115509
  • Shower seat non-powered :
  • ,
  • Patient transfer sliding mat :
  • ,
  • Shower seat power-adjusted :
  • ,
  • Assistive stool/step :
  • ,
  • Wheelchair electric-motor-driven attendant/occupant-controlled powered-steering non-collapsible :
  • ,
  • Wheelchair electric-motor-driven attendant/occupant-controlled powered-steering collapsible :
  • ,
  • Patient lifting system bath chair :
  • ,
  • Raised toilet seat :
  • ,
  • Bath board :
  • ,
  • Commode :
Invacare PortugalRua da Estrada Velha 949

Leca do Balio
4465-784

Portugal

INVACARE UK OPERATIONS LIMITEDUK Responsible PersonUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ
UK Responsible Person
United Kingdom
06/25/202115511
  • Basic electric home bed :
  • ,
  • Standing transfer platform electric :
  • ,
  • Overhead track patient lifting/transfer system :
Invacare Rea ABVaxjovagen 303

Dio
SE-343 71

Sweden

INVACARE UK OPERATIONS LIMITEDUK Responsible PersonUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ
UK Responsible Person
United Kingdom
06/25/202115507
  • Bariatric bed :
  • ,
  • Basic walking frame non-foldable :
  • ,
  • Basic walking frame foldable :
  • ,
  • Basic electric home bed :
INVACARE UK OPERATIONS LIMITEDUnit 4 Pencoed Technology Park
Pencoed
Bridgend
CF35 5AQ

United Kingdom







11/24/202010970
  • Wheelchair seat cushion :
  • ,
  • Alternating-pressure bed mattress overlay reusable :
  • ,
  • Alternating-pressure bed mattress :
  • ,
  • Wheelchair attendant/occupant-driven bimanual-lever-operated collapsible :
INVAMED SAGLIK ILAC SAN VE TIC ASMutlukent 1961. Cd. No:27 Cankaya

ANKARA
06800

Turkey

Zeela LtdUK Responsible PersonS&F Reform Road
Clyde House
Maidenhead
Berkshire SL6 8BY
UK Responsible Person
England United Kingdom
04/13/202211950
  • Varicose vein adhesive-treatment kit :
  • ,
  • Peripheral angioplasty balloon catheter drug-coated :
  • ,
  • Neurovascular embolization coil :
Invatec SpAVia Martiri della Liberta 7 Roncadelle

Brescia
25030

Italy
01923212213
Medtronic LimitedUK Responsible PersonBuilding 9 Croxley Park

Watford
Herts WD18 8WW
UK Responsible Person
England United Kingdom
03/03/202212940
  • Bare-metal renal artery stent :
  • ,
  • Peripheral angioplasty balloon catheter drug-coated :
  • ,
  • Carotid artery embolic protection system :
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • Peripheral angioplasty balloon catheter basic :
  • ,
  • Carotid artery embolic protection system :
  • ,
  • Peripheral angioplasty balloon catheter basic :
  • ,
  • Peripheral angioplasty balloon catheter basic :
Invenio Imaging Inc.2310 Walsh Avenue

Santa Clara
95051

United States

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
06/15/202224904
  • Histology/cytology/microbiology image-analysis interpretive software IVD :
  • ,
  • Microscope slide digital imaging scanner IVD :
  • ,
  • General specimen microscopy slide IVD single-use :
Invent Medic Sweden ABNytänkargatan 4

Lund
SE-22363

Sweden

iMEDicare LTDUK Responsible Person27 Rosemary Drive

St. Albans
Hertfordshire AL2 1UD
UK Responsible Person
England United Kingdom
darren@imedicare.co.uk
11/23/202227037
  • Urinary-incontinence vaginal insert reusable :
Inventis S.r.lCorso Stati Uniti 1/3

Padova
35127

Italy

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
06/08/202215870
  • Impedance audiometer :
  • ,
  • Pure-tone audiometer :
  • ,
  • Audiometric/hearing aid tester :
  • ,
  • Otoscope direct :
  • ,
  • Hearing aid tester electrical :
Inverness Dental LaboratoryInverness dental Lab 16 A Telford Street

INVERNESS
Inverness Shire IV3 5JZ

United Kingdom







04/11/20134133
  • Dental bridge metal-ceramic :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Gold dental inlay :
  • ,
  • Bonded dental bridge :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental impression tray single-use :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental veneer professional :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Complete upper denture :
  • ,
  • Bite registration rim wax plate :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Partial denture :
  • ,
  • Complete lower denture :
INVIA LLC3025 Boardwalk Street Suite 200

Ann Arbor
Michigan 48108

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/21/202120367
  • Radiology DICOM image processing application software :
Invictus Global Limited3-4 Oaktree Business Park Cadley Hill Road
Swadlincote
Swadlincote
Other (Non US) DE11 9DJ

England United Kingdom







05/17/202114713
  • Infant bed restraint :
  • ,
  • Stair chair :
  • ,
  • Stairclimber :
  • ,
  • Patient lifting system stretcher :
  • ,
  • Utility trolley :
  • ,
  • Hospital stretcher manual :
  • ,
  • Hospital stretcher manual :
  • ,
  • Patient positioning vacuum mattress :
  • ,
  • Patient isolation capsule :
Invidia Medical GmbH & Co.KGCarl-Benz-Str. 28

Tuttlingen
Emmingen-Liptingen 78576

Germany

Schultz Medical (UK) LtdUK Responsible PersonSchultz Medical (UK) Ltd Unit 6 Commerce Park
Crowland Street
Southport
Lancashire PR9 7RL
UK Responsible Person
England United Kingdom
10/11/202118171
  • Open-surgery biopsy forceps reusable :
  • ,
  • Rigid bronchoscope :
  • ,
  • Rigid intubation laryngoscope reusable :
  • ,
  • Rigid cystoscope :
  • ,
  • Rigid arthroscope reusable :
  • ,
  • Rigid nasopharyngoscope :
  • ,
  • Resectoscope :
  • ,
  • Rigid optical thoracoscope :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Dental casting noble alloy :
  • ,
  • Endoscope camera adaptor :
  • ,
  • Rigid optical hysteroscope :
  • ,
  • Rigid endoscope working guide :
  • ,
  • Endoscope sheath reusable :
  • ,
  • Electromechanical device/system transport trolley :
  • ,
  • Endoscopic electrosurgical electrode monopolar reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Meniscus knife :
  • ,
  • Endoscope video camera :
  • ,
  • Urethrotome :
  • ,
  • Otoscope endoscopic :
  • ,
  • Flexible endoscopic scissors reusable :
  • ,
  • Rigid optical laparoscope :
  • ,
  • Rigid endoscopic biopsy forceps reusable :
  • ,
  • Rigid oesophagoscope :
  • ,
  • Rigid ureterorenoscope :
  • ,
  • Biliary/urinary stone retrieval basket reusable :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Open-surgery electrosurgical handpiece/electrode monopolar reusable :
  • ,
  • Electrocautery system line-powered :
Invivo a division of Philips Medical Systems12151 Research Parkway

Orlando
Florida 32826

United States

Philips Electronics UK LtdUK Responsible PersonAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW
UK Responsible Person
England United Kingdom
09/16/202117559
  • Electronic thermometer probe cover :
  • ,
  • Intravenous line recessed-needle connector :
  • ,
  • Continuous electronic patient thermometer battery-powered :
  • ,
  • Pulse oximeter probe single-use :
  • ,
  • Electrocardiography telemetric monitoring system :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Electrocardiographic electrode single-use :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • MRI system synchronizer :
  • ,
  • Patient monitoring system module pulse oximetry :
  • ,
  • Pulse oximeter probe reusable :
  • ,
  • Pulse oximeter probe reusable :
  • ,
  • Paper chart recorder :
  • ,
  • Blood pressure cuff reusable :
  • ,
  • Exhaled-gas sample collector non-electronic :
  • ,
  • Electrocardiographic lead set reusable :
Invivo Corporation3545 SW 47th Avenue

Gainesville
Florida 32608

United States

Philips Electronics UK LtdUK Responsible PersonAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW
UK Responsible Person
England United Kingdom
08/16/202116812
  • Skin marking sticker :
  • ,
  • Bone access cannula :
  • ,
  • Needle guide single-use :
  • ,
  • MRI system application software :
  • ,
  • Ultrasound imaging system application software :
Invivo Corporation3545 SW 47th Avenue

Gainesville
Florida 32608

United States

Philips Electronics UK LtdUK Responsible PersonAscent 1 Farnborough Aerospace Centre

Farnborough
Hampshire GU14 6XW
UK Responsible Person
England United Kingdom
10/01/202119017
  • MRI system coil radio-frequency :
  • ,
  • Needle guide single-use :
  • ,
  • Needle guide single-use :
  • ,
  • Needle guide single-use :
  • ,
  • Needle guide single-use :
  • ,
  • MRI system coil radio-frequency :
Invivoscribe IncInvivoscribe Inc 10222 Barnes Canyon Road Bldg. 1

San Diego
California 92121-2711

United States

Gillian Pawlowsky LtdUK Responsible Person272 Bath Street

Glasgow
G2 4JR
UK Responsible Person
Scotland United Kingdom
02/01/202222546
  • T-cell lymphoma IVD kit nucleic acid technique (NAT) :
  • ,
  • Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • B-cell malignancy IVD kit nucleic acid technique (NAT) :
Invotec6833 Phillips Industrial Blvd Jacksonville

Florida
32256-3029

United States

Severn Healthcare Technologies LtdUK Responsible Person21 Broadwalk Pinner Road

North Harrow
Middlesex HA2 6ED
UK Responsible Person
United Kingdom
04/26/202113855
  • External nasal splint :
  • ,
  • Wound dressing kit non-medicated :
  • ,
  • Silicone-sheet tissue reconstructive material non-sterile :
  • ,
  • Diamond ENT bur single-use :
  • ,
  • Dry medical towel/wipe single-use :
  • ,
  • Electromyographic endotracheal tube electrode :
  • ,
  • Endoscope sheath single-use :
  • ,
  • External nasal splint :
  • ,
  • Intranasal splint non-biodegradable :
  • ,
  • Metal/carbide ENT bur single-use :
  • ,
  • Mouthguard single-use :
  • ,
  • Nasal haemostatic balloon :
  • ,
  • Nasal septal button :
  • ,
  • Silicone-sheet tissue reconstructive material sterile :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Tympanostomy tube :
  • ,
  • Tympanotomy knife single-use :
  • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
Invuity Inc444 De Haro Street San Francisco

San Francisco
California 94107

United States

Stryker UK LtdUK Responsible PersonStryker House Hambridge Road

Newbury
Berkshire RG14 5AW
UK Responsible Person
England United Kingdom
10/08/202118106
  • Surgical/emergency suction cannula illuminating single-use : Surgical/emergency suction cannula illuminating single-use Conformity Assessment Certificate Expired
  • ,
  • Fibreoptic retractor handle : Fibreoptic retractor handle Conformity Assessment Certificate Expired
  • ,
  • Fibreoptic operating light system : Fibreoptic operating light system Conformity Assessment Certificate Expired
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Fibreoptic light cable :
Inzek International Trading BVVissenstraat 32

Apeldoorn
Provincie Gelderland 7324 AL

Netherlands

Dawn Asset Management LimitedUK Responsible PersonKalamu House Coldbath Square

London
EC1R 5HL
UK Responsible Person
England United Kingdom
04/20/202216090
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD kit rapid ICT clinical :
  • ,
  • Fluorescent immunoassay analyser IVD point-of-care line-powered :
  • ,
  • Thyroxine antibody IVD kit fluorescent immunoassay :
  • ,
  • Troponin I IVD kit fluorescent immunoassay :
  • ,
  • Procalcitonin (PCT) IVD kit fluorescent immunoassay :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassay :
  • ,
  • D-dimer IVD kit fluorescent immunoassay :
  • ,
  • Cystatin C IVD kit rapid ICT clinical :
  • ,
  • Microalbumin IVD kit rapid ICT clinical :
  • ,
  • Neutrophil gelatinase-associated lipocalin (NGAL) IVD kit fluorescent immunoassay :
  • ,
  • Serum amyloid A IVD kit rapid ICT clinical :
  • ,
  • Luteinizing hormone (LH) IVD kit fluorescent immunoassay rapid :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit rapid ICT clinical :
  • ,
  • Prolactin IVD kit fluorescent immunoassay :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit rapid ICT clinical :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassay :
  • ,
  • Total triiodothyronine (TT3) IVD kit fluorescent immunoassay :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassay :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapid :
  • ,
  • Ferritin IVD kit fluorescent immunoassay :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD kit fluorescent immunoassay rapid :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassay :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Salmonella typhi antigen IVD kit rapid ICT clinical :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
  • ,
  • D-dimer IVD kit rapid ICT clinical :
  • ,
  • 125-Dihydroxy vitamin D3 IVD calibrator :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
IOB Medical Inc.504 E Diamond Avenue Suite I

Gaithersburg
MD 20877

United States

Prosum Medical LimitedUK Responsible PersonUnit 14 Cowley Mill Road Trade City Business Park

Uxbridge
UB8 2DB
UK Responsible Person
England United Kingdom
03/15/202223615
  • Circulating-air whole-body heating/cooling system pad single-use :
  • ,
  • Circulating-air whole-body heating system control unit : Circulating-air whole-body heating system control unit Conformity Assessment Certificate Expired
  • ,
  • Circulating-air whole-body heating/cooling system pad single-use sterile : Circulating-air whole-body heating/cooling system pad single-use sterile Conformity Assessment Certificate Expired
IOLLA GROUP LtdUnit M13 145 Charles Street

Glasgow
Lanarkshire G21 2QA

Scotland United Kingdom







04/09/20225648
  • Prescribed Spectacles :
  • ,
  • Spectacle Lenses :
  • ,
  • Ready-Made Spectacles (Non-Prescribed) :
  • ,
  • Spectacle Frames :
  • ,
  • Prescription spectacles :
IOLUTION GmbHRuhrstr. 13 Germany

Hamburg
22761

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202218613
  • Manual intraocular lens injector single-use :
Ion Beam Application S.A.Chemin du Cyclotron 3

Louvain-la-Neuve
1348

Belgium

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202215429
  • Proton therapy system :
  • ,
  • Radiation therapy digital imager :
IOPI Medical LLC18500 156th Ave NE STE104
Woodinville
Woodinville
WA98072

United States

Severn Healthcare Technologies LtdUK Responsible Person21 Broadwalk Pinner Road

North Harrow
Middlesex HA2 6ED
UK Responsible Person
United Kingdom
04/15/202113421
  • Dynamometer force gauge :
IProdens GmbHQuarzstrasse 8

Hanau
63450

Germany

Synergy Direct ServicesUK Responsible Person110 Athlestan Way Stretton

Burton on Trent
Staffordshire DE13 0XZ
UK Responsible Person
England United Kingdom
10/11/202118202
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Temporary dental crown/bridge :
IPS Converters ltdWestwood House Featherstall Road South

Oldham
Lancashire OL9 6HS

United Kingdom







04/08/20224943
  • Incontinence Pads And Accessories :
  • ,
  • Disposable Hand Towels Used In Scrubbing Up :
  • ,
  • Ward Dressing Packs :
  • ,
  • Theatre Dressing Packs :
  • ,
  • Oral Hygiene Packs :
  • ,
  • Ophthalmic Surgical Procedure Packs :
  • ,
  • Orthodontic Procedure Packs :
  • ,
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
  • ,
  • Dry medical towel/wipe single-use :
  • ,
  • Surgical towel :
iQ HealthTechHanover House 5 Hanover Close

Christchurch
Dorset BH23 2FA

United Kingdom







04/15/202210655
  • Clinical information system web-based application software :
  • ,
  • Clinical information system web-based application software :
IQ MEDICALUnit 1A The Wharf Stretton Under Fosse

RUGBY
Warwickshire CV23 0PR

England United Kingdom
01788 833989
sales@iqmedical.co.uk






10/15/20228292
  • Alternating-pressure chair cushion system :
  • ,
  • Alternating-pressure bed mattress :
IQ Products B.V.Rozenburglaan 13a

Groningen
9727 DL

Netherlands

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
12/31/202121007
  • Foeto-maternal haemorrhage/Kleihauer test IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
  • ,
  • CD103 cell marker IVD antibody :
  • ,
  • CD138 cell marker IVD antibody :
  • ,
  • Platelet factor 4-heparin complex total antibody IVD kit rapid agglutination clinical :
IRADIMED CORPORATION1025 WILLA SPRINGS DRIVE

WINTER SPRNGS
FLORIDA 32708

United States

Medical Device Consultancy LtdUK Responsible Person7 Pinewood Drive Ashley Heath
Market Drayton
Market Drayton
TF9 4PA
UK Responsible Person
England United Kingdom
08/17/202217320
  • Bedside infusion pump single-channel :
  • ,
  • Electric infusion pump administration set single-use :
  • ,
  • Electrocardiographic electrode single-use :
  • ,
  • MRI-patient physiologic monitoring system :
  • ,
  • Intravenous pole :
iRhythm Technologies Inc699 8th Street
Suite 600
San Francisco
California 94103

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/15/202117598
  • Electrocardiographic ambulatory recorder :
Iridex Corporation1212 Terra Bella Avenue

Mountain View
California 94043

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
03/29/202223881
  • General/multiple surgical diode laser system :
  • ,
  • General/multiple surgical frequency-doubled solid-state laser system :
  • ,
  • Foot-switch electrical :
  • ,
  • Ophthalmic laser system beam guide :
  • ,
  • General/multiple surgical frequency-doubled solid-state laser system :
IROMED GROUP S.r.lVia tempio del cielo 3/5

Rome
00144

Italy

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
03/07/202215748
  • Ophthalmic ultraviolet phototherapy system :
  • ,
  • Ophthalmic ultraviolet phototherapy solution :
iRT Systems GmbHSchlossstrasse 1

Koblenz
56068

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202218297
  • Accelerator system quality assurance device :
Irvine Biomedical Inc. a St. Jude Medical Company2375 Morse Avenue

Irvine
California 92614

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
02/13/202112108
  • Cardiac radio-frequency ablation system catheter :
  • ,
  • Intracardiac ultrasound imaging catheter steerable single-use :
  • ,
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Electrical-only medical device connection cable reprocessed :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac mapping catheter percutaneous single-use : Cardiac mapping catheter percutaneous single-use Conformity Assessment Certificate Expired
Isakssons Gummifabrik ABÄngalagsvägen 226

Båstad
269 95

Sweden

LC BjarnramUK Responsible Person25 Stroudes Close

Worcester Park
KT4 7RB
UK Responsible Person
England United Kingdom
01/17/202221260
  • Rubber dam Hevea-latex :
Isansys Lifecare Ltd8C Park Square Milton Park Milton

Abingdon
Oxfordshire OX14 4RR

United Kingdom







08/26/20166053
  • Continuous electronic patient thermometer battery-powered :
  • ,
  • Physiological measuring device wireless data capture/transfer unit :
iSchemaView Inc.1120 Washington Ave Ste 200 Office 108

Golden CO.
80401

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
09/24/202117762
  • Radiology PACS software :
ISDIN SAProvencals 33

Barcelona
08019

Spain

Espère Healthcare LtdUK Responsible PersonUnit 11D Old Bridge Way

Shefford
Bedfordshire SG17 5HQ
UK Responsible Person
England United Kingdom
04/12/202216646
  • Superficial skin exfoliant professional :
ISFY INTERNATIONAL pvt.8G Mushtaq Gurmani Road

Lahore
Gulberg II

Pakistan

ISFY LtdUK Responsible Person51 Cromer Road Tooting

LONDON
SW17 9Jn
UK Responsible Person
United Kingdom
05/05/202224520
  • Suturing needle holder reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Rubber dam clamp :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Dental surgical scissors :
  • ,
  • Orthodontic metal band pusher :
  • ,
  • Orthodontic appliance dimension gauge :
  • ,
  • Dental mirror reusable :
ISFY Ltd51 Cromer Road Tooting

LONDON
SW17 9Jn

United Kingdom







04/14/20229857
  • Orthodontic pliers :
  • ,
  • Dental anaesthesia syringe single-use :
  • ,
  • Dental syringe needle single-use :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Dental spatula reusable :
  • ,
  • Margin finishing dental file/rasp reusable :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Surgical/examination garment kit :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Dental restoration carver amalgam reusable :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental excavator reusable :
  • ,
  • Dental explorer :
  • ,
  • Dental restoration carver resin :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Dental surgical scissors :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Orthodontic appliance dimension gauge :
  • ,
  • Orthodontic ligature director :
  • ,
  • Orthodontic metal band pusher :
  • ,
  • Periodontal curette :
  • ,
  • Periodontal hoe :
  • ,
  • Periodontal probe reusable :
  • ,
  • Periotome reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Periodontal probe reusable :
  • ,
  • Rubber dam frame :
  • ,
  • Orthodontic pliers :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Dental restoration carver amalgam reusable :
  • ,
  • Dental excavator reusable :
  • ,
  • Dental explorer :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Orthodontic ligature director :
  • ,
  • Dental spatula reusable :
  • ,
  • Periodontal curette :
  • ,
  • Dental restoration carver resin :
  • ,
  • Endodontic plugger :
  • ,
  • Rubber dam kit :
  • ,
  • Periotome reusable :
  • ,
  • Dental anaesthesia syringe single-use :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
ISKO KOCH GmbHEgerländer Straße 28

Bayreuth
Bavaria 95448

Germany

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
02/01/202222039
  • Electrical assistive bed :
  • ,
  • Freestanding patient lifting system electrically-powered :
Iskra Medical d.o.o.Stegne 23

Ljubljana
1000

Slovenia

Beautyform Medical LtdUK Responsible PersonSouth View Lower Wall Road

Hythe
Kent CT21 4NW
UK Responsible Person
England United Kingdom
erkan@beautyform.co.uk
05/11/202224541
  • Deep-tissue electromagnetic stimulation system professional :
Island Polymer Industries GmbHANDRESENSTR 6

Bitterfeld-wolfen
06766

Germany

CellPath LtdUK Responsible PersonUnit 80 Mochdre Enterprise Park

Newtown
Powys SY16 4LE
UK Responsible Person
United Kingdom
11/07/202119582
  • Microscope slide coverslip IVD :
Isle of Wight NHS TrustHospital Sterilization & Disinfection Unit St Mary's Hospital
Parkhurst Road
Newport
Isle of Wight PO30 5TG

United Kingdom







08/05/202010416
  • Podiatry kit reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Urological surgical procedure kit non-medicated reusable :
  • ,
  • Bone/joint surgical power tool motorized handpiece/set pneumatic :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Ophthalmic surgical procedure kit non-medicated reusable :
  • ,
  • Obstetrical/gynaecological surgical procedure kit non-medicated reusable :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • General surgical procedure kit non-medicated reusable :
  • ,
  • ENT surgical procedure kit non-medicated reusable :
  • ,
  • Arthroscopic surgical procedure kit non-medicated reusable :
ISODENT OYValtakatu 4 D

Rovaniemi
96100

Finland

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
05/23/202224729
  • Denture cleanser :
  • ,
  • Orthodontic appliance cleanser :
  • ,
  • Dental mouthwash :