Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
Beverley OpticsHagley Unit 2 Hagley Hall Mews

Stourbridge
West Midlands DY9 9LG

United Kingdom








08/25/99561
  • Spectacle Frames :
Beverley VE Ltd12 Toll Gavel

Beverley
North Humberside HU17 9AJ

United Kingdom








10/26/20095091
  • Prescribed Spectacles :
Bewdley Dental Practice51-52 Load Street

Bewdley
Worcestershire DY12 2AP

United Kingdom








11/27/20142612
  • Dental Appliances/Prostheses :
Bexleyheath VE Limited5 The Mall Broadway Shopping Centre

Bexleyheath
Kent DA6 7JJ

United Kingdom








03/06/20072793
  • Prescribed Spectacles :
Bexpo Int’l Company16/384 Power House New Abadi

Sialkot
Punjab 51310

Pakistan

Blue Star Company 786 LimitedAuthorised Representative40-Thorncliffe Road Norwood Green Southall Middx

London
UB2 5RQ

United Kingdom
'+44(33)33031126
02/04/202111974
  • Manual dental scaler, reusable :
  • ,
  • Cast cutting scissors :
  • ,
  • Corneal scissors :
  • ,
  • Dental collar/crown scissors :
  • ,
  • Dental surgical scissors :
  • ,
  • Ear scissors, reusable :
  • ,
  • ENT wire-cutting scissors :
  • ,
  • Episiotomy scissors, reusable :
  • ,
  • General-purpose surgical scissors, reusable :
  • ,
  • Gynaecological scissors, reusable :
  • ,
  • Nail scissors, reusable :
  • ,
  • Nail splitting scissors :
  • ,
  • Nasal scissors :
  • ,
  • Neurosurgical scissors :
  • ,
  • Ophthalmic strabismus scissors :
  • ,
  • Ophthalmic suture scissors :
  • ,
  • Suture scissors :
  • ,
  • Tonsil scissors :
  • ,
  • Umbilical cord scissors, reusable :
  • ,
  • Vascular scissors :
  • ,
  • Bandage scissors, reusable :
  • ,
  • Blepharoplasty scissors :
  • ,
  • Conjunctival scissors :
  • ,
  • Embryotomy scissors :
  • ,
  • Airway obstruction forceps :
  • ,
  • Bone cutting forceps :
  • ,
  • Bone distraction forceps :
  • ,
  • Bone holding forceps :
  • ,
  • Cilia forceps :
  • ,
  • Clamp manipulation forceps :
  • ,
  • Dental dressing forceps, reusable :
  • ,
  • Dressing/utility forceps, tweezers-like, reusable :
  • ,
  • Forceps jar :
  • ,
  • Nail extraction forceps :
  • ,
  • Nail splitting forceps, reusable :
  • ,
  • Nasal septum straightening forceps :
  • ,
  • Obstetrical forceps, reusable :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Scalp clip forceps :
  • ,
  • Tonsil punch forceps :
  • ,
  • Tooth extraction forceps :
  • ,
  • Tunnelling forceps :
  • ,
  • Wire holding/twisting forceps :
  • ,
  • Bone lever/elevator :
  • ,
  • Dental elevator, tooth/root :
  • ,
  • ENT elevator :
  • ,
  • Periosteal elevator, reusable :
  • ,
  • Uterine elevator :
  • ,
  • Tuning fork :
  • ,
  • Dental cheek retractor, professional, reusable :
  • ,
  • Hand-held dental retractor :
  • ,
  • Hand-held surgical retractor, reusable :
  • ,
  • Nerve/vessel retractor :
  • ,
  • Self-retaining surgical retractor, reusable :
  • ,
  • Bone hook :
  • ,
  • Eye muscle hook, reusable :
  • ,
  • Soft-tissue surgical hook, reusable :
  • ,
  • Ear speculum, reusable :
  • ,
  • Eyelid speculum, reusable :
  • ,
  • Nasal speculum, reusable :
  • ,
  • Rectal speculum :
  • ,
  • Self-retaining ear speculum :
  • ,
  • Vaginal speculum, reusable :
  • ,
  • Suturing needle holder, reusable :
  • ,
  • Dental explorer :
  • ,
  • Dental excavator, reusable :
  • ,
  • Rubber dam clamp :
  • ,
  • Towel clamp, reusable :
  • ,
  • Umbilical cord clamp, reusable :
  • ,
  • ENT probe, reusable :
  • ,
  • Fistula probe :
  • ,
  • Lacrimal probe, reusable :
  • ,
  • Periodontal probe, reusable :
  • ,
  • Orthodontic pliers :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Wire holding/twisting pliers :
  • ,
  • Wire-extracting pliers :
  • ,
  • Bone curette, reusable :
  • ,
  • Dermal curette :
  • ,
  • General-purpose curette :
  • ,
  • Ophthalmic curette, reusable :
  • ,
  • Periodontal curette :
  • ,
  • Lacrimal dilator, reusable :
  • ,
  • Rectal dilator, reusable :
  • ,
  • Urethral dilator, reusable :
  • ,
  • Bone cutter :
  • ,
  • Manual dental burnisher, reusable :
  • ,
  • Dental amalgam condenser, reusable :
  • ,
  • Dental restoration carver, amalgam, reusable :
  • ,
  • Dental wax carver :
  • ,
  • Mouth gag support, reusable :
  • ,
  • Mouth gag, adjustable, reusable :
  • ,
  • Mouth gag, non-adjustable :
  • ,
  • Tongue depressor, examination, reusable :
  • ,
  • Tongue depressor, surgical :
  • ,
  • Laryngoscope blade, reusable :
  • ,
  • Laryngoscope handle, reusable :
  • ,
  • Scalpel handle, reusable :
  • ,
  • Manual scalpel blade, reusable :
  • ,
  • Dura mater dissector :
  • ,
  • ENT suction dissector :
  • ,
  • Periocular/lacrimal retractor, hand-held, reusable :
  • ,
  • Periocular/lacrimal retractor, self-retaining :
  • ,
  • Radial surgical retractor :
  • ,
  • Craniofacial rongeur, reusable :
  • ,
  • Dental rongeur :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Rib rongeur :
  • ,
  • Spinal rongeur :
  • ,
  • Abdominal/intestinal spatula :
  • ,
  • Bladder spatula :
  • ,
  • Dental spatula, reusable :
  • ,
  • General-purpose surgical spatula :
  • ,
  • Orthopaedic cement spatula :
  • ,
  • Vascular spatula :
  • ,
  • ENT trocar blade :
  • ,
  • Tonsil dissector, reusable :
  • ,
  • Chisel/osteotome blade handle :
  • ,
  • Dental osteotome :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Ear knife :
  • ,
  • Orthopaedic knife :
  • ,
  • Nasal knife :
  • ,
  • Bone file/rasp, manual, reusable :
  • ,
  • Nasal file/rasp :
  • ,
  • Periodontal file/rasp, manual :
  • ,
  • Plastic surgery file/rasp :
  • ,
  • Toenail file/rasp, reusable :
  • ,
  • Dental matrix band retainer :
  • ,
  • Orthodontic retainer :
  • ,
  • Cast spreader :
  • ,
  • Bladder neck spreader :
  • ,
  • Rib spreader, reusable :
  • ,
  • Otoscope, direct :
  • ,
  • Dental articulator :
  • ,
  • Dental amalgam carrier :
  • ,
  • Ring cutter :
  • ,
  • Suture cutter, reusable :
  • ,
  • Wire cutter :
  • ,
  • Dental torque wrench :
  • ,
  • Dental torque wrench adaptor :
  • ,
  • Incus hook :
  • ,
  • Percussion hammer, manual :
  • ,
  • Tracheal surgery dilator, reusable :
Bfactory Health Products B.V.Remmerden 58

Rhenen
3911 TZ

Netherlands

Oswell Penda Pharmaceutical LTDUK Responsible Person14 Park Drive

Oswestry
Shropshire SY11 1BW

England United Kingdom

08/03/202116448
  • Skin osmotic dressing, antimicrobial :
  • ,
  • Wound-nonadherent dressing, permeable, antimicrobial :
  • ,
  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial :
  • ,
  • Collagen wound matrix dressing :
BFB Labs LtdShift Design 71 St. John Street
2nd Floor
LONDON
EC1M 4NJ

United Kingdom








05/21/202010054
  • Mindfulness/behavioural therapy software, clinician-consultative :
BG Optics Ltd11 Cockhedge Way Cockhedge Centre

Warrington
Cheshire WA1 2QQ

United Kingdom








10/14/20155296
  • Prescribed Spectacles :
BGI Europe A/SOle Maaløes Vej 3

Copenhagen
DK-2200

Denmark

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom

09/07/202117963
  • Human genomic analysis interpretive software :
  • ,
  • Nucleic acid library construction kit IVD :
BHM-Tech Produktionsgesellschaft mbHBHM-Tech Produktionsgesellschaft mbH Grafenschachen 242
7423 Grafenschachen
Grafenschachen
7423 Grafenschachen

Austria

Starkey Laboratories ltdUK Responsible PersonWilliam F Austin House Bramhall Technology Park
Pepper Road Hazel Grove
Stockport
Cheshire SK7 5BX

United Kingdom

06/08/202115160
  • Bone-conduction hearing aid, head-worn :
  • ,
  • Air-conduction hearing aid, wearable case :
Bicester Dental Care98 sheep street

bicester
OX26 6LP

United Kingdom








11/21/20175731
  • Dental Appliances/Prostheses :
Bicester Ve Limited31 Sheep Street

Bicester
Oxfordshire OX26 6JJ

United Kingdom








09/25/20072933
  • Prescribed Spectacles :
Bicon LLC501 Arborway
501 Arborway
Boston
MA 02130

United States

Bicon Marketing LimitedUK Responsible Person1 Abacus House Newlands Road

Corsham
Wiltshire SN13 0BH

England United Kingdom

04/09/202113228
  • Basket endosteal dental implant, two-piece :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Fixture/appliance dental drill bit, reusable :
  • ,
  • Dental bone matrix implant, synthetic :
  • ,
  • Instrument tray, reusable :
  • ,
  • Bone curette, reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Dental implantation depth/angle gauge, reusable :
  • ,
  • Surgical mallet :
  • ,
  • Orthodontic pliers :
  • ,
  • General-purpose absorbent tip applicator/swab, single-use :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Dental irrigation/aspiration syringe :
  • ,
  • Stationary x-ray grid :
  • ,
  • Dental osteotome set :
  • ,
  • Dental osteotome :
  • ,
  • Dappen dish, reusable :
  • ,
  • Root canal post thread cutter :
  • ,
  • Periotome, reusable :
  • ,
  • Dental implant system :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Dental implant abutment analog, scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental prosthesis/implant abutment screw :
Bicton Dental Services13 Bicton Place

Exmouth
Devon EX8 2SU

United Kingdom








08/25/99333
  • Dental Appliances/Prostheses :
Biedermann Motech GmbH & Co. KGBertha-von-Suttner Straße 23

Villingen-Schwenningen
Baden-Württemberg 78054

Germany

Biedermann Motech International Ltd.UK Responsible Person4 Wharfe Mews Cliffe Terrace

Wetherby
LS22 6LX

England United Kingdom

06/22/202115436
  • Metallic spinal interbody fusion cage :
  • ,
  • Bone-screw internal spinal fixation system, non-sterile :
  • ,
  • Vertebral body prosthesis :
Bieffe Medital SpA trading as Baxter SondaloVia Stelvio 94

Sondalo
(SO) 23035

Italy

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ

England United Kingdom

08/04/202116528
  • Haemodialysis concentrate :
  • ,
  • Haemodialysis citrate anticoagulation solution :
  • ,
  • Haemodialysis dialysate solution :
Biegler GmbHAllhangstrasse 18a

Mauerbach
3001

Austria

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL

United Kingdom

07/14/202115971
  • Convection blood/fluid warmer set :
  • ,
  • Conduction blood/fluid warmer :
  • ,
  • Incentive spirometer :
  • ,
  • CNS-modulation periauricular nerve percutaneous electrical stimulator :
  • ,
  • Intravenous pressure infusor, automated :
Bien-Air Dental SALänggasse 60

Bienne
2504

Switzerland

Bien-Air UK LtdUK Responsible PersonFirst Floor Ridgeland House 15 Carfax

Horsham
West Sussex RH12 1DY

England United Kingdom

10/06/202118054
  • Remotely-driven surgical/dental system drive cable :
  • ,
  • Dental power tool system handpiece, remotely-driven :
  • ,
  • Remotely-driven dental drilling system motor :
  • ,
  • Pneumatic dental drilling system hose :
  • ,
  • Dental power tool system handpiece, pneumatic :
  • ,
  • Surgical power tool system control unit, line-powered :
  • ,
  • Pneumatic dental handpiece coupler :
  • ,
  • Surgical instrument maintenance lubricant :
Bien-Air Surgery SABien-Air Surgery SA
Rue De L'ouest 2b
Le Noirmont
Jura 2340

Switzerland

Delta Surgical LimitedUK Responsible PersonUnit 10 Evolution Lymedale Business Park

Newcastle under Lyme
Staffordshire ST5 9QF

United Kingdom

11/25/202117813
  • Middle ear drill bit :
  • ,
  • Foot-switch, electrical :
  • ,
  • Craniotomy power tool system handpiece, line-powered :
  • ,
  • Surgical power tool system control unit, line-powered :
  • ,
  • ENT shaver system :
  • ,
  • Trephining power tool attachment :
  • ,
  • Drilling power tool attachment, basic :
  • ,
  • Multi-purpose surgical power tool system, line-powered :
  • ,
  • Multi-purpose surgical power tool system, rechargeable battery-powered :
  • ,
  • Diamond ENT bur, single-use :
  • ,
  • Metal/carbide ENT bur, reusable :
  • ,
  • Electrical-only medical device connection cable, reusable :
  • ,
  • Line-powered surgical power tool system motor :
  • ,
  • ENT shaver system handpiece :
  • ,
  • Diamond ENT bur, reusable :
  • ,
  • Metal/carbide ENT bur, single-use :
  • ,
  • Cranial bur, single-use :
  • ,
  • ENT suction dissector :
Big Health Ltdc/o Simkins LLP Lynton House
7-12 Tavistock Square
LONDON
WC1H 9LT

United Kingdom








10/09/20188160
  • Cognitive training software :
Big Picture Medical Limited 15th Floor 6 Bevis Marks

London
EC3A 7BA

United Kingdom








11/18/20199253
  • Clinical management support software :
Bill Fyall Dental DesignUnit B2 Birdineye Farm Framfield Road

Uckfield
East Sussex. TN22 5HA

United Kingdom








07/01/20095068
  • Dental Appliances/Prostheses :
Bill Jago Dental Laboratory Ltd6 Robins Park Loddiswell

Kingsbridge
Devon TQ7 4SL

United Kingdom








07/08/20113727
  • Custom-made dental crown, ceramic :
  • ,
  • Custom-made dental crown, metal/polymer :
  • ,
  • Custom-made dental crown, polymer :
  • ,
  • Dental veneer, professional :
  • ,
  • Dental bridge, ceramic :
  • ,
  • Bar dental precision attachment :
  • ,
  • Magnetic dental precision attachment :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Root canal post, custom-made :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge, metal-ceramic :
  • ,
  • Dental bridge, metal-polymer :
  • ,
  • Dental bridge, polymer :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Custom-made dental crown, metal :
  • ,
  • Custom-made dental crown, metal/ceramic :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Teeth whitening tray :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental implant suprastructure, permanent, custom-made :
BILL & TAYLOR OPTICAL LABORATORIES.1ST Floor 13 Wolborough Road Newton Abbot

Devon.
TQ12 1JR

United Kingdom








08/25/991378
  • Prescribed Spectacles :
Billy @ Glasses123292 Park Road Toxteth

Liverpool
Merseyside L8 4UE

United Kingdom








06/11/20144519
  • Spectacle Lenses :
Bingley Dental ServicesLower Ground Clifby Works
Sandbeds Road Pellon
Halifax
West Yorkshire HX2 0QQ

United Kingdom








05/31/20134170
  • Dental Appliances/Prostheses :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Denture reliner, elastic, long-term :
  • ,
  • Denture reliner, elastic, short-term :
  • ,
  • Denture reliner, hard :
  • ,
  • Overdenture :
  • ,
  • Denture reliner, soft, professional :
  • ,
  • Dental impression tray, reusable :
  • ,
  • Dental impression tray, single-use :
  • ,
  • Dental occlusal splint, customizable :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Partial denture :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim wax, plate :
  • ,
  • Orthodontic clasp, metal wire, custom-made :
  • ,
  • Orthodontic clasp, metal, custom-made :
  • ,
  • Custom-made organ/bone anatomy model :
  • ,
  • Vacuum mouldable splint :
  • ,
  • Preformed complete denture :
  • ,
  • Bite registration rim :
  • ,
  • Custom-made mouthguard :
  • ,
  • Fluoride gel tray :
  • ,
  • Orthodontic retainer :
  • ,
  • Denture clasp, metal, custom-made :
  • ,
  • Denture clasp, metal, preformed :
  • ,
  • Denture clasp, polymer, preformed :
Binnington & Thurling. Opticians.17 Micklegate York.

York
North Yorkshire YO1 6JH

United Kingdom








08/25/991400
  • Prescribed Spectacles :
binx health LtdDerby Court Epsom Square White Horse Business Park

Trowbridge
Wiltshire BA14 0XG

United Kingdom








10/07/20144480
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care :
Bio-Art Equipamentos Odontologicos LtdaRua Teotonio Vilela

Sao Carlos
Sao Carlos 120 Jd. Tangara

Brazil

Panadent LimitedUK Responsible Person149 sevenoaks way

Orpington
Kent BR5 3AQ

United Kingdom

08/12/202116748
  • Dental impression tray material :
  • ,
  • Facebow :
  • ,
  • Dental articulator :
  • ,
  • Magnifying spectacles :
Bio-Diagnostics LtdUpton Industrial Estate Rectory Road
Upton-upon-Severn
Worcester
Worcestershire WR8 0LX

United Kingdom








08/25/996957
  • Multi-purpose surgical skin adhesive tape :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid :
Bio-Med Devices Inc.61 Soundview Road

Guilford
CT 06437

United States

Inspiration Healthcare LimitedUK Responsible PersonUnit 2 Satellite Business Village
Fleming Way
CRAWLEY
West Sussex RH10 9NE

United Kingdom

11/08/202118894
  • Oxygen/air breathing gas mixer, hospital :
  • ,
  • Transport electric ventilator :
Bio-Rad Laboratories Inc. Clinical Immunology Division (CID)5500 East 2nd St.

Benicia
California 94510

United States

BIO-RAD LABORATORIES LIMITEDUK Responsible PersonThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom

12/29/202121625
  • :
Bio-Rad Laboratories Inc. Clinical Systems Division (CSD)4000 Alfred Nobel Drive

Hercules
94547

United States

BIO-RAD LABORATORIES LIMITEDUK Responsible PersonThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom

12/29/202121626
  • :
Bio-Rad Laboratories Inc. (DBG - Digital Biology Group)5731 West Las Positas Blvd.

Pleasanton
California 94588

United States

BIO-RAD LABORATORIES LIMITEDUK Responsible PersonThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom

12/29/202121628
  • :
Bio-Rad Medical Diagnostics GmbHIndustriestr.1

Dreieich
D-63303

Germany

BIO-RAD LABORATORIES LIMITEDUK Responsible PersonThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom

12/29/202121631
  • :
Bio-Rad3 boulevard Raymond Poincaré

Marnes-la-Coquette
92430

France

BIO-RAD LABORATORIES LIMITEDUK Responsible PersonThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom

12/29/202121629
  • :
Bio-Solutions International Ltd92 Westgate

Guisborough
Cleveland TS14 6AP

United Kingdom








03/22/20113681
  • Rehabilitation Equipment :
  • ,
  • Airway Devices/Monitoring Equipment And Accessories :
BIO-TECH VISION CARE PVT. LTD.Plot No. 555-556-557 Opp. Subham Tex-OPack Khatraj-Vadsar Road P.O.: Khatraj
Taluka Kalol Dist. Gandhinagar Gujarat
Gandhinagar
382721

India

NEUVIDA MEDICAL DEVICE INC LIMITEDUK Responsible Person25 Leeming Road

Borehamwood
Hertfordshire WD6 4EB

England United Kingdom

04/30/202114226
  • Dermal tissue reconstructive material, microbe-derived :
  • ,
  • Vitreous/aqueous humour replacement medium, intraoperative :
  • ,
  • Intraocular retractor, single-use :
  • ,
  • Vitreous humour replacement medium, postoperative :
  • ,
  • Anterior-chamber intraocular lens, pseudophakic :
  • ,
  • Posterior-chamber intraocular lens, pseudophakic :
  • ,
  • Capsular tension ring :
  • ,
  • Manual intraocular lens injector, single-use :
  • ,
  • Intraocular lens-insertion cartridge :
  • ,
  • Ophthalmic sponge :
  • ,
  • Schirmer tear test strip :
  • ,
  • Corneal staining strip :
  • ,
  • Ophthalmic knife, single-use :
  • ,
  • Ophthalmic surgical dye :
  • ,
  • Intracorneal ring segment :
  • ,
  • Synovial fluid supplementation medium :
Bio-Technology General Ltd.Be'er Tuvia Industrial Zone P.O. Box 571

Kiryat Malachi 8310402
8310402

Israel

Ferring Pharmaceuticals LtdUK Responsible PersonDrayton Hall Church Road
West Drayton
West Drayton
UB7 7PS

England United Kingdom

01/18/202219336
  • Synovial fluid supplementation medium :
  • ,
  • Vitreous/aqueous humour replacement medium, intraoperative :
Bio Compression Systems Inc120 W. Commercial Avenue

Moonachie
New Jersey 7074

United States

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

Cambridge
CB24 9BZ

England United Kingdom

10/18/202118385
  • Intermittent venous compression system :
  • ,
  • Single-chamber venous compression system garment, reusable :
  • ,
  • Hot/cold therapy pack, reusable :
  • ,
  • Multi-chamber venous compression system garment, reusable :
  • ,
  • Intermittent venous compression system pump :
  • ,
  • Sequential venous compression system pump :
Bio Molecular Systems Pty Ltd5-7 Tonka St

Yatala
QLD 4207

Australia

Bio Molecular Systems LtdUK Responsible Person22 Chancery Lane

London
WC2A 1LS

England United Kingdom

01/17/202221280
  • :
Bio Optica Milano S.p.ABio-Optica Milano S.p.A
Via San Faustino 58 MILANO
MI
Lombardia 20134

Italy

AnatoPath LimitedUK Responsible PersonThe Haven London Road

Darsham
Suffolk NR338TU

England United Kingdom

11/12/202119064
  • Biopsy tissue marking dye kit IVD :
  • ,
  • Biological stain IVD :
  • ,
  • Histology tissue cassette IVD, laboratory processing :
  • ,
  • Tissue embedding mould IVD, reusable :
  • ,
  • Tissue embedding unit IVD :
  • ,
  • Microscope slide stainer IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Autopsy/dissection sink system :
  • ,
  • Laboratory water bath :
  • ,
  • Paraffin wax oven :
BioArray Solutions Ltd.35 Technology Drive Suite 100

Warren
New Jersey 7059

United States

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

Oxford
OX1 2EP

England United Kingdom

04/29/202114170
  • Multiple blood group genotyping IVD, reagent :
  • ,
  • HLA class I & II antigen tissue typing IVD, kit, multiplex :
Biocare Enterprise LtdFlat 01A 9/F Brill Plaza 84 Tokwawan Road Kowloon

Hong Kong
Hong Kong of China N/A

China

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom

09/21/202117619
  • Musculoskeletal/physical therapy laser, home-use :
Biocartis NVGeneraal De Wittelaan 11 B3

Mechelen
2800

Belgium

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

Cambridge
CB24 9BZ

England United Kingdom

12/29/202121609
  • :
Biocentric SAS276 chemin de Roumpinas
BANDOL
Toulon
Var 83150

France

Bruker UK LimitedUK Responsible PersonBanner Lane

Coventry
CV4 9GH

England United Kingdom

12/22/202121434
  • :
BioCer Entwicklungs-GmbHLudwig-Thoma-Strasse 36c

Bayreuth
Bavaria 95447

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG

England United Kingdom

07/08/202115811
  • Plant polysaccharide haemostatic agent, bioabsorbable :
  • ,
  • Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
Biochemical Diagnostics Inc180 Heartland Blvd.

Edgewood
New York 11779

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom

12/29/202121583
  • :
Biochemical Systems International SPAGalleria San Babila 4B

Milan
20122

Italy

SYRINGA UK LTDUK Responsible PersonUnit G Daux Road

Billingshurst
RH14 9SR

England United Kingdom

10/06/202118072
  • Glucose/ketone/lipid monitoring system IVD, home-use :
Biochrom LtdUnit 7 Enterprise Zone 3970 Cambridge Research Park
Beach Drive Waterbeach
Cambridge
Cambridgeshire CB25 9PE

England United Kingdom








11/26/20199338
  • Phenylalanine IVD, kit, ion exchange chromatography :
  • ,
  • Amino acid analyser IVD, automated :
Biocomma LimitedB1605-B1606 Life Science Park Shenchengtou Creative Factory Julongshan A Road Xiuxin Community Kengzi Street Pingshan District

Shenzhen
Guangdong 518118

China

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

London
W1H 1PJ

United Kingdom

12/23/202120882
  • :
Biocompatibles UK LimitedChapman House Weydon Lane
Chapman House GBR
FARNHAM
Surrey GU9 8QL

United Kingdom








02/27/20198551
  • Chemotherapeutic agent embolization particle :
  • ,
  • Embolization particle, non-bioabsorbable :
  • ,
  • Manual-afterloading brachytherapy system source delivery procedure kit :
  • ,
  • Manual-afterloading brachytherapy system storage container :
  • ,
  • Manual brachytherapy source, permanent implant :
Biocomposites LtdMed I C 4 Building Keele University Science Park Keele

Newcastle
Staffordshire ST5 5NL

United Kingdom








06/23/20056897
  • Orthopaedic bone screw, bioabsorbable :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Bone matrix implant, synthetic, non-antimicrobial :
  • ,
  • Synthetic bone graft :
  • ,
  • Bone graft delivery kit :
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom








01/28/202111835
  • Neisseria gonorrhoeae culture isolate identification IVD, kit :
  • ,
  • Oxidase production microbial reagent IVD :
  • ,
  • Catalase production microbial reagent IVD :
  • ,
  • Multiple Neisseria species culture isolate identification IVD, kit :
  • ,
  • Indole/Kovac's microbial reagent IVD :
  • ,
  • Differential/selective agar culture medium IVD :
  • ,
  • Hippurate hydrolase microbial reagent IVD :
  • ,
  • Urea differentiation disc IVD :
  • ,
  • Chromogenic substrate reagent IVD :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent :
  • ,
  • Nitrate reduction microbial reagent IVD :
  • ,
  • Coagulase production microbial reagent IVD :
  • ,
  • Basic/simple nutrient agar culture medium IVD :
Biocore Co. Ltd.Room 605 ACE Techno Tower 5h 20 Digital-ro 31-gil Guro-gu

Seoul
08380

South Korea

Ananta International LimitedUK Responsible Person11 Hampden Close Upper Cambourne

Cambridge
CB23 6AW

England United Kingdom

03/30/202113049
  • Reverse transcription reagent kit IVD :
Biodan Medical Internationalc/o Quality manager Unit 1 Stroudwater Business Park

Stonehouse
Gloucestershire GL10 3SX

United Kingdom








08/25/993364
  • Non-Invasive Electrodes/Transducers And Accessories :
  • ,
  • Adhesive Plasters/Dressings/Tapes/Barrier Films :
  • ,
  • Incision Drapes/Theatre Clothing :
BioDerm Inc.12320 73rd Court North

Largo
Florida 33773

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom

01/07/202219712
  • Hypoallergenic skin adhesive tape :
  • ,
  • Urinary incontinence penis sheath/port, single-use :
  • ,
  • Incontinence penis clamp, reusable :
  • ,
  • Wearable percutaneous catheter/tube holder :
  • ,
  • Synthetic-polymer liquid barrier dressing, non-sterile :
Biodex Medical Systems Inc.20 Ramsay Road

Shirley
New York 11967

United States

NB Insight LtdUK Responsible Person39 Lambourn Avenue Stone Cross
Pevensey
Pevensey
East Sussex BN24 5PQ

England United Kingdom

12/17/202118978
  • Biomechanical function analysis system, force-testing, stationary :
BioDue S.p.A.Via A. Lorenzetti 3/A Loc. sambuca Val di Pesa
50028 Barberino Tavarnelle
Florence
50028

Italy

Pettifor Healthcare LimitedUK Responsible PersonThe Homestead Barnby Road Balderton

Newark
Nottinghamshire NG24 3NE

England United Kingdom

11/15/202119658
  • Eye lubricant :
BioElectronics Corporation4539 Metropolitan Court

Frederick MD
21704

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom

07/13/202115888
  • Hand-held deep-tissue electromagnetic stimulator :
Bioengineering Laboratories SrlVia Antonio Vivaldi 32/A

Cantù
Como 22063

Italy

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX

England United Kingdom

09/02/202117118
  • Gastrointestinal manometric catheter, non-electronic :
  • ,
  • Urodynamic manometric catheter, non-electronic :
  • ,
  • Intra-abdominal pressure measurement set, mechanical :
Bioengineering Services(Part of Rehabilitation Engineering Services)Eastern General Hospital Seafield Street

Edinburgh
EH6 7LN

United Kingdom








07/30/20025378
  • External Limb Prostheses And Accessories :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Orthoses And Prostheses - External (Made Direct From Casts/Prescriptions) :
  • ,
  • Rehabilitation Equipment :
BioFire Diagnostics LLC515 Colorow Drive Salt Lake City

Utah
Salt Lake City UT84108

United States

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom

04/08/202113189
  • Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated :
Biofrontera Pharma GmbHHemmelrather Weg 201

Leverkusen
51377

Germany

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

Cambridge
CB24 9BZ

England United Kingdom

01/17/202221269
  • :
Biofrost Viking Lab Oy LtdRovaniementie 305

Ivalo
99800

Finland

Win Health Medical LtdUK Responsible PersonUnit 1 Oxnam Road Industrial Estate
Jedburgh
Jedburgh
TD8 6LS

United Kingdom

01/14/202221268
  • :
BioGend Therapeutics Co Ltd4F No 3 Park Street

Taipei City
Nangang District 115

Taiwan

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom

06/03/202115142
  • Pulsed signal therapy system extremity coil :
Biohit Healthcare (Hefei) Co. Ltd.Biouhan Bio-Industrial Park Northeast Corner Intersection of Kongquetai Road and Chang'an Road
High-Tech Zone
Hefei
Anhui Province 230000

China

Vatic Health LimitedUK Responsible Person9th Floor 107 Cheapside

London
EC2V 6DN

England United Kingdom

07/27/202116162
  • SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid :
Biohit OYJLaippatie 1

Helsinki
FI-00880

Finland

BIOHIT HealthCare LtdUK Responsible PersonPioneer House Pioneer Business Park
North Road
Ellesmere Port
Cheshire CH65 1AD

England United Kingdom

regulatory@neoventa.com
01/19/202219851
  • Helicobacter pylori urease IVD, kit, chromogenic :
  • ,
  • Helicobacter pylori urease IVD, control :
  • ,
  • Lactase IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Lactase IVD, control :
  • ,
  • Tissue transglutaminase antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid :
BioHorizons Implant Systems Inc.2300 Riverchase Center

Birmingham Alabama
35244

United States

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW

England United Kingdom

05/27/202010070
  • Dental implant analog :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical torque wrench, reusable :
  • ,
  • Dental implantation depth/angle gauge, reusable :
  • ,
  • Bone tack inserter, basic :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Dental soft-tissue coring punch, reusable :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Dental osteotome :
  • ,
  • Dental implant abutment analog, scanning :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Instrument tray, reusable :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Membrane fixation tack, non-bioabsorbable :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Fixture/appliance dental drill bit, single-use :
  • ,
  • Dental implant x-ray template :
  • ,
  • Screw endosteal dental implant, two-piece :
  • ,
  • Bone tap, single-use, sterile :
  • ,
  • Manual non-rotary dental instrument handle :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Diamond dental bur, reusable :
  • ,
  • Bone tap, reusable :
  • ,
  • Steel dental bur, reusable :
  • ,
  • Carbide dental bur, reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable :
  • ,
  • Fixture/appliance dental drill bit, reusable :
BioHorizons Implant Systems Inc2300 Riverchase Center

Birmingham
Alabama 35244

United States

BioHorizons UK LtdUK Responsible PersonRichmond House Oldbury Road

Bracknell
Berkshire RG12 8TQ

England United Kingdom

09/02/202117230
  • Dental amalgam condenser, reusable :
  • ,
  • Dental implantation depth/angle gauge, reusable :
  • ,
  • Surgical torque wrench, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • General-purpose surgical spatula :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable :
  • ,
  • Manual non-rotary dental instrument handle :
  • ,
  • Centrifuge bucket/tube holder :
  • ,
  • Steel dental bur, reusable :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable :
  • ,
  • Dental soft-tissue coring punch, reusable :
  • ,
  • Fixture/appliance dental drill bit, reusable :
  • ,
  • Electrical mains power cable :
  • ,
  • Haematological concentrate system :
  • ,
  • Screw endosteal dental implant, two-piece :
  • ,
  • Dental power tool converter attachment, rotary :
  • ,
  • Centrifuge rotor, ultracentrifuge :
  • ,
  • Instrument tray, reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • General-purpose bowl, reusable :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Dental implant abutment analog, scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental prosthesis/implant abutment screw analog, reusable :
  • ,
  • Dental precision attachment fitting/adjustment tool :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental instrument depth limiter :
BioIntegral Surgical1-200 Britannia Rd E Unit 1

MISSISSAUGA
L4Z 1S6

Canada

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

Cambridge
CB24 9BZ

England United Kingdom

04/30/202114216
  • Aortic heart valve bioprosthesis :
  • ,
  • Pulmonary heart valve bioprosthesis :
  • ,
  • Cardiovascular patch, animal-derived :
  • ,
  • Vascular xenograft :
BIOKIT S.A.Av. Can Montcau 7 08186 Lliçà d'Amunt Barcelona

Barcelona
08186

Spain

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE

England United Kingdom

09/16/202117511
  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent :
  • ,
  • Rheumatoid factor IVD, kit, agglutination :
  • ,
  • Coagulation factor X IVD, control :
  • ,
  • von Willebrand factor: collagen binding activity (vWF:CBA) IVD, reagent :
  • ,
  • Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Fibrinogen degradation product (FDP) IVD, calibrator :
  • ,
  • Fibrinogen degradation product (FDP) IVD, control :
  • ,
  • Fibrinogen degradation product (FDP) IVD, kit, agglutination :
  • ,
  • Chemiluminescent immunoassay analyser IVD, automated :
  • ,
  • Buffered wash solution IVD, manual :
  • ,
  • Buffered sample diluent IVD, manual :
  • ,
  • Plasma protein IVD, calibrator :
  • ,
  • Plasma protein IVD, control :
  • ,
  • Beta-2-microglobulin IVD, calibrator :
  • ,
  • Digitoxin therapeutic drug monitoring IVD, control :
  • ,
  • Lipoprotein A IVD, calibrator :
  • ,
  • Lipoprotein A IVD, control :
  • ,
  • Myoglobin IVD, calibrator :
  • ,
  • Ferritin IVD, calibrator :
  • ,
  • Rheumatoid factor IVD, calibrator :
  • ,
  • D-dimer IVD, kit, agglutination :
  • ,
  • D-dimer IVD, control :
  • ,
  • D-dimer IVD, calibrator :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator :
  • ,
  • Lipoprotein A IVD, kit, nephelometry/turbidimetry :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Ferritin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin E (IgE total) IVD, calibrator :
  • ,
  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry :
  • ,
  • Digitoxin therapeutic drug monitoring IVD, calibrator :
  • ,
  • Myoglobin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry :
  • ,
  • Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry :
  • ,
  • Culture tube :
BioLegend Inc.8999 Biolegend Way

San Diego
California 92121

United States

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

Cambridge
CB24 9BZ

England United Kingdom

11/08/202119615
  • D2-40 antigen IVD, kit, enzyme immunohistochemistry :
  • ,
  • Gross cystic disease fluid protein-15 IVD, kit, enzyme immunohistochemistry :
  • ,
  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry :
Biolife LLC8163 25th Court East

Sarasota
Florida 34243

United States

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

Cambridge
CB24 9BZ

England United Kingdom

08/25/202117067
  • Inorganic haemostatic agent, sterile :
Bioline Products s.r.o.Krakovská 1338/10
Krakovská Praha 1
Praha
Hlavní město Praha 110 00

Czechia

Enteromed LtdUK Responsible Person85 Great Portland Street First Floor

London
W1W 7LT

England United Kingdom

11/10/202118275
  • Mineral-based gastrointestinal detoxifier :
Biolog-id1 rue du Commandant Robert Malrait

ZA des Granges Bernay
27303

France

Easy Medical Device LimitedUK Responsible Person125 Deansgate

Manchester
M3 2LH

Wales United Kingdom

11/08/202119447
  • Blood bank information system :
bioLytical Laboratories Inc.406-13251 Delf Place

Richmond
British Columbia V6V 2A2

Canada

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom

04/21/202113307
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control :
  • ,
  • SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 total antibody IVD, control :
  • ,
  • HIV1/HIV2 antibody IVD, control :
  • ,
  • HIV1/HIV2/Treponema pallidum antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test :
  • ,
  • Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Hepatitis C virus total antibody IVD, control :
Biomatlante SAZA les Quatre Nations 5 Rue Edouard Belin

Vigneux de Bretagne
44360

France

Advanced Medical Solutions LtdUK Responsible PersonPremier Park 33 Road One
Winsford Industrial Estate
Winsford
Cheshire CW7 3RT

United Kingdom

04/12/202113288
  • General oral wound dressing, animal-derived :
  • ,
  • Bone matrix implant, synthetic, non-antimicrobial :
  • ,
  • Orthopaedic bone screw, bioabsorbable :
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom
020 3198 2420
03/30/202113038
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • HIV1 antigen neutralization IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • HIV1 antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus e-antigen/antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, reagent :
  • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent :
  • ,
  • Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD, kit :
  • ,
  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Human parechovirus (HPeV) nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple gram negative bacteria species culture isolate identification IVD, kit :
  • ,
  • Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD, reagent :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Indole/Kovac's microbial reagent IVD :
  • ,
  • Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Dengue virus antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus nucleic acid IVD, control :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Protein C IVD, kit, fluorescent immunoassay :
  • ,
  • Antifungal minimum inhibitory concentration (MIC) IVD :
  • ,
  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • D-dimer IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Gram stain IVD, reagent :
  • ,
  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Prolactin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent :
  • ,
  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free cortisol IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Progesterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Myoglobin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit :
  • ,
  • Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit :
  • ,
  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent :
  • ,
  • Helicobacter pylori transport medium IVD :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Differential/selective broth culture medium IVD :
  • ,
  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD :
  • ,
  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood :
  • ,
  • Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay :
  • ,
  • Fastidious-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Optical instrument performance standard calibrator/control IVD, single-use :
  • ,
  • Thyroglobulin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Buffered sample diluent IVD, automated/semi-automated system :
  • ,
  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Amies transport medium IVD :
  • ,
  • Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Basic/simple nutrient broth culture medium IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Pipette tip IVD :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay :
  • ,
  • McFarland standard IVD :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay :
  • ,
  • Interferon gamma release IVD, control :
  • ,
  • Basic/simple nutrient agar culture medium IVD :
  • ,
  • Multiple formulation agar culture medium IVD :
  • ,
  • Enriched broth culture medium IVD :
  • ,
  • Microbial identification mass spectrometry system IVD :
  • ,
  • Enriched agar culture medium IVD :
  • ,
  • Multiple bacteria species culture isolate identification control IVD, kit :
  • ,
  • Multiple bacteria carbapenemase production IVD, kit, chromogenic :
  • ,
  • Fluorescent immunoassay analyser IVD, laboratory, automated :
  • ,
  • Microscope slide stainer IVD :
  • ,
  • Nucleic acid sample preparation instrument IVD, automated :
  • ,
  • T-cell activation/stimulated interferon release IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Carcinoembryonic antigen (CEA) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent :
  • ,
  • Catalase production microbial reagent IVD :
  • ,
  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Clostridium difficile antigen IVD, antibody :
  • ,
  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated :
  • ,
  • Tryptophan utilization/spot indole microbial reagent IVD :
  • ,
  • Nephelometry/turbidimetry analyser IVD, manual :
  • ,
  • ONPG (ortho-nitrophenyl-beta-galactoside) differentiation disc IVD :
  • ,
  • Optochin/ethylhydrocupreine differentiation disc IVD :
  • ,
  • Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Troponin I IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Hepatitis E virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Differential/selective agar culture medium IVD :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Ferritin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple Candida/yeast species culture isolate identification IVD, kit :
  • ,
  • Coagulase production microbial reagent IVD :
  • ,
  • Indole broth/peptone water microbial reagent IVD :
  • ,
  • Oxidase production microbial reagent IVD :
  • ,
  • Antibacterial minimum inhibitory concentration (MIC) IVD :
  • ,
  • General-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Multiple Neisseria species culture isolate identification IVD, kit :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Nucleic acid technique (NAT) kit IVD :
  • ,
  • Laboratory instrument/analyser application software IVD :
bioMérieux UK LtdChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom
02476 323372







01/13/202111530
  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD :
  • ,
  • kit :
  • ,
  • enzyme immunoassay (EIA) :
BIOMEC SRLVIA NAZIONALE NORD 21/A

COLICO (LC)
23823

Italy

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG

England United Kingdom

11/06/202118860
  • Screw endosteal dental implant, two-piece :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable :
BioMedica Diagnostics Inc94 Wentworth Road PO Box 1030

Windsor
Nova Scotia B0N 2T0

Canada

Invitech LtdUK Responsible PersonUnit 4 Molesworth Business Estate Molesworth

Huntingdon
Cambs PE28 0QG

United Kingdom

11/10/202119295
  • Lupus anticoagulant marker IVD, kit, clotting :
  • ,
  • Lupus anticoagulant marker IVD, control :
  • ,
  • D-dimer IVD, kit, agglutination :
Biomedica su Misura SRLVia Rieti 8

Brescia
25125

Italy

Kinetec Medical Products UK LtdUK Responsible Person16-20 Morris Close Park Farm Industrial Estate

Wellingborough
Northants NN8 6XF

England United Kingdom
'+441302490030
info@ukca-experts.com
01/11/202221186
  • :
Biomedical Data Solutions LimitedCentrum Point Third Avenue
Centrum 100
Burton Upon Trent
Staffordshire DE14 2WD

United Kingdom








12/02/20199376
  • Laboratory instrument/analyser application software IVD :
BIOMEDICAL SHOES S.L.POLIGONO EL RUBIAL CALLE 2 NUMERO 13

ALICANTE
VILLENA 3400

Spain

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom

09/03/202117288
  • Orthotic shoe, ready-made :
Biomeme Incorporated1015 Chestnut Street Suite 1401

Philadelphia
Pennsylvani PA 19107

United States

Nuevo International Bio Security UK LimitedUK Responsible Person11-17 Fowler Road Hainault Business Park

Ilford
Essex IG6 3UJ

England United Kingdom

04/27/202113960
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care :
bioMerieux Inc100 Rodolphe Street

Durham
NC 27712

United States

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom

04/08/202113190
  • Multiple anaerobic bacteria species culture isolate identification IVD, kit :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit :
  • ,
  • Multiple gram negative bacteria species culture isolate identification IVD, kit :
  • ,
  • Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit :
  • ,
  • General-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Optical instrument performance standard calibrator/control IVD, reusable :
  • ,
  • Basic/simple nutrient broth culture medium IVD :
  • ,
  • Sterile saline suspension medium/diluent IVD :
  • ,
  • Differential/selective broth culture medium IVD :
  • ,
  • Multiple Candida/yeast species culture isolate identification IVD, kit :
  • ,
  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated :
  • ,
  • Blood culture analyser IVD, automated :
  • ,
  • Microbial identification mass spectrometry system IVD :
Biomet 3i LLC4555 Riverside Dr

Palm Beach Gardens
Florida 33410

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

04/26/202113883
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Screw endosteal dental implant, two-piece :
  • ,
  • Bone trephine :
  • ,
  • Bone tap, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch, reusable :
  • ,
  • Fixture/appliance dental drill bit, reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable :
  • ,
  • Steel dental bur, reusable :
Biomet Biologics LLC56 East Bell Drive

Warsaw
Indiana IN 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

11/15/202118256
  • General oral wound dressing, animal-derived :
  • ,
  • Haematological concentrate system delivery unit :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
  • ,
  • Orthopaedic trocar blade, single-use :
  • ,
  • Haematological concentrate system :
Biomet France SARL58 Avenue de Lautagne BP 75 Valence Cedex 9

Surwold
26903

Germany

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

05/14/202114643
  • Mobile-bearing total knee prosthesis :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Coated hip femur prosthesis, modular :
  • ,
  • Total shoulder prosthesis :
  • ,
  • Acetabular shell :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, sterile :
  • ,
  • Bone matrix implant, animal-derived, non-bioabsorbable :
  • ,
  • Uncoated femoral stem prosthesis, modular :
  • ,
  • Orthopaedic cement, non-antimicrobial :
  • ,
  • Orthopaedic cement, antimicrobial :
  • ,
  • Body femoral/tibial extension stem, uncoated :
  • ,
  • Orthopaedic prosthesis implantation instrument, reusable :
  • ,
  • Manual orthopaedic cement mixer, reusable :
  • ,
  • Orthopaedic cement dispenser :
  • ,
  • Orthopaedic cement compressor :
  • ,
  • Orthopaedic cement spatula :
  • ,
  • Orthopaedic material preparation vacuum pump :
Biomet Microfixation1520 Tradeport Drive

Jacksonville
Florida 32218

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

05/18/202114755
  • Craniofacial bone screw, bioabsorbable :
  • ,
  • Bone matrix implant, synthetic, non-antimicrobial :
  • ,
  • Craniofacial fixation plate, bioabsorbable :
  • ,
  • Sternal fixation device :
  • ,
  • Cranioplasty sheet :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Total temporomandibular joint prosthesis :
  • ,
  • Cranioplasty plate, alterable :
  • ,
  • Craniofacial bone screw, non-bioabsorbable, sterile :
  • ,
  • Craniofacial fixation plate, non-bioabsorbable :
  • ,
  • Orthopaedic fixation plate, non-bioabsorbable, sterile :
  • ,
  • Cranioplasty plate screw :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Temporary mandibular condyle prosthesis :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, non-sterile :
  • ,
  • Funnel chest remodelling bar :
  • ,
  • Orthopaedic bone washer, non-sterile :
  • ,
  • Orthodontic wire :
  • ,
  • Bone tap, reusable :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • Orthopaedic knife :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Orthopaedic bur, reusable :
  • ,
  • Bone tap, single-use, non-sterile :
  • ,
  • Surgical implant/trial-implant/sizer holder, reusable :
  • ,
  • Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, reusable :
  • ,
  • Iliofemoral vein stent :
  • ,
  • Screw extractor, reusable :
  • ,
  • Endoscopic control/video-imaging system :
Biomet Orthopaedics LLC56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

05/28/202114983
  • Uncoated knee femur prosthesis, metallic :
  • ,
  • Uncoated knee tibia prosthesis, metallic :
  • ,
  • Posterior-stabilized total knee prosthesis :
  • ,
  • Coated knee femur prosthesis :
  • ,
  • Coated knee tibia prosthesis :
  • ,
  • Polyethylene patella prosthesis :
  • ,
  • Tibial insert :
  • ,
  • Knee arthroplasty wedge :
  • ,
  • Orthopaedic bone pin, non-bioabsorbable :
  • ,
  • Orthopaedic cement spacer mould :
  • ,
  • Acetabular shell :
  • ,
  • Reverse shoulder prosthesis base plate :
  • ,
  • Reverse shoulder prosthesis head :
  • ,
  • Shoulder prosthesis screw :
  • ,
  • Acetabulum prosthesis hole plug :
  • ,
  • Femoral head/stem prosthesis adaptor :
  • ,
  • Reverse shoulder prosthesis body :
  • ,
  • Shoulder humeral body prosthesis :
  • ,
  • Humeral stem extension prosthesis :
  • ,
  • Femoral stem centralizer :
  • ,
  • Coated shoulder humeral stem prosthesis :
  • ,
  • Press-fit femoral stem prosthesis :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Coated hip femur prosthesis, modular :
  • ,
  • Uncoated knee tibia/insert prosthesis :
  • ,
  • Bipolar femoral head outer component, hemiarthroplasty :
  • ,
  • Uncoated elbow humerus prosthesis :
  • ,
  • Partial shoulder prosthesis :
  • ,
  • Orthopaedic cement spacer :
  • ,
  • Uncoated femoral stem prosthesis, one-piece :
  • ,
  • Uncoated hip femur prosthesis, modular :
  • ,
  • Coated femoral stem prosthesis, modular :
  • ,
  • Polyethylene reverse shoulder prosthesis cup :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, sterile :
  • ,
  • Constrained polyethylene acetabular liner :
  • ,
  • Metallic acetabular liner :
  • ,
  • Knee femur stem prosthesis :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, non-sterile :
  • ,
  • Stem-fixed humeral head prosthesis :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Surgical saw blade, sagittal, single-use :
  • ,
  • Orthopaedic implant inserter/extractor, reusable :
  • ,
  • Bone awl :
  • ,
  • Manual bone mill :
  • ,
  • Fluted surgical drill bit, single-use :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Bone-resection orthopaedic reamer, reusable :
  • ,
  • Surgical saw blade, reciprocating, single-use :
  • ,
  • Surgical saw blade, oscillating, single-use :
  • ,
  • Surgical implant template, reusable :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Orthopaedic implant/instrument adaptor, reusable :
  • ,
  • Orthopaedic implant/instrument adaptor, single-use :
  • ,
  • Femoral head prosthesis trial :
  • ,
  • Acetabulum prosthesis trial, prefabricated, reusable :
  • ,
  • Femoral stem prosthesis trial :
  • ,
  • Patella prosthesis trial :
  • ,
  • Knee femur prosthesis trial :
  • ,
  • Knee tibia prosthesis trial :
  • ,
  • Humeral head prosthesis trial, reusable :
  • ,
  • Shoulder glenoid fossa prosthesis trial :
  • ,
  • Humeral stem prosthesis trial :
  • ,
  • Elbow radius prosthesis trial :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Wire cutter :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Medullary canal orthopaedic reamer, flexible :
  • ,
  • Bone file/rasp, manual, reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Manual surgical rotary handpiece, reusable :
  • ,
  • Orthopaedic osteotome blade, reusable :
  • ,
  • Elbow humerus prosthesis trial :
  • ,
  • Mobile-bearing total ankle prosthesis :
  • ,
  • Orthopaedic bone nut :
  • ,
  • Humeral centering sleeve :
  • ,
  • Topical liquid dose dispenser :
  • ,
  • Body femoral/tibial extension stem, coated :
Biomet Spain Orthopaedics SLCalle Islas Baleares 50 Fuente del Jarro

Valencia
46988

Spain

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

05/14/202114672
  • Uncoated knee tibia prosthesis, metallic :
  • ,
  • Metal-on-polyethylene total hip prosthesis :
Biomet Sports Medicine56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

04/26/202113921
  • Soft-tissue/mesh anchor, non-bioabsorbable :
  • ,
  • Tendon/ligament bone anchor, non-bioabsorbable :
  • ,
  • Ligament reconstruction instrument set, reusable :
  • ,
  • Suturing unit, single-use :
  • ,
  • Orthopaedic bone nut :
  • ,
  • Humeral centering sleeve :
  • ,
  • Orthopaedic bone pin, non-bioabsorbable :
  • ,
  • Orthopaedic bone screw, bioabsorbable :
  • ,
  • Knee femur stem prosthesis :
  • ,
  • Sleeve femoral/tibial extension, uncoated :
  • ,
  • Cannulated surgical drill bit, reusable :
  • ,
  • Operative-site suture holder :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • General/plastic surgical procedure kit, non-medicated, single-use :
  • ,
  • Surgical drill guide obturator :
  • ,
  • Medullary canal orthopaedic reamer, flexible :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Suturing unit, reusable :
  • ,
  • Fluted surgical drill bit, single-use :
  • ,
  • Orthopaedic surgical procedure kit, non-medicated, single-use :
  • ,
  • Arthroscopic surgical procedure kit, non-medicated, single-use :
  • ,
  • Bone nail guidewire, reusable :
  • ,
  • Orthopaedic trocar blade, reusable :
  • ,
  • Surgical drill guide, single-use :
  • ,
  • Arthroscopic access cannula, single-use :
  • ,
  • Suturing needle, single-use :
  • ,
  • Bone awl :
  • ,
  • Surgical countersink, reusable :
  • ,
  • Bone tap, reusable :
  • ,
  • Bone-resection orthopaedic reamer, reusable :
  • ,
  • Hard-tissue ultrasonic surgical system handpiece tip :
  • ,
  • Cannulated surgical drill bit, single-use, sterile :
Biomet Trauma56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonThe Courtyard Lancaster Place
South Marston Park
Swindon
Wiltshire SN3 4FP

England United Kingdom

04/26/202113878
  • Orthopaedic bone wire :
  • ,
  • Tibia nail, sterile :
  • ,
  • Humerus nail, sterile :
  • ,
  • Bone nail end-cap :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, sterile :
  • ,
  • Orthopaedic fixation plate, non-bioabsorbable, sterile :
  • ,
  • Orthopaedic bone washer, sterile :
  • ,
  • Orthopaedic bone pin, non-bioabsorbable :
  • ,
  • Femur nail, sterile :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, non-sterile :
  • ,
  • Femur nail, non-sterile :
  • ,
  • Bone-screw internal spinal fixation system, non-sterile :
  • ,
  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile :
  • ,
  • Orthopaedic bone washer, non-sterile :
  • ,
  • Cannulated surgical drill bit, reusable :
  • ,
  • Orthopaedic implant inserter/extractor, reusable :
  • ,
  • Surgical countersink, reusable :
  • ,
  • Bone tap, reusable :
  • ,
  • Surgical drill chuck :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Surgical torque wrench, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Medullary canal orthopaedic reamer, flexible :
  • ,
  • Fluted surgical drill bit, single-use :
  • ,
  • Manual orthopaedic bender, reusable :
  • ,
  • Medullary canal orthopaedic reamer, rigid :
  • ,
  • Bone tap, single-use, non-sterile :
  • ,
  • Surgical screwdriver, single-use, non-sterile :
  • ,
  • Surgical countersink, single-use :
  • ,
  • Orthopaedic implantation sleeve, reusable :
  • ,
  • Orthopaedic implant/instrument adaptor, reusable :
  • ,
  • Bone tap, single-use, sterile :
  • ,
  • Surgical drill guide, single-use :
  • ,
  • Orthopaedic implantation sleeve, single-use :
  • ,
  • Surgical screwdriver, single-use, sterile :
  • ,
  • Surgical implant template, single-use :
  • ,
  • Cannulated surgical drill bit, single-use, sterile :
  • ,
  • Bone nail guidewire, reusable :
Biomet UK LimitedWaterton Industrial Estate

Bridgend
CF31 3XA

Wales United Kingdom








06/19/201362
  • Elbow humerus prosthesis trial :
  • ,
  • Elbow ulna prosthesis trial :
  • ,
  • Metal-backed elbow ulna prosthesis :
  • ,
  • Coated elbow humerus prosthesis :
  • ,
  • Uncoated elbow humerus prosthesis :
  • ,
  • Polyethylene patella prosthesis :
  • ,
  • Coated hip femur prosthesis, modular :
  • ,
  • Uncoated knee femur prosthesis, metallic :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Uncoated knee tibia/insert prosthesis :
  • ,
  • Coated knee femur prosthesis :
  • ,
  • Uncoated femoral stem prosthesis, one-piece :
  • ,
  • Polyethylene acetabulum prosthesis :
  • ,
  • Unicondylar knee prosthesis :
  • ,
  • Ceramic femoral head prosthesis :
  • ,
  • Acetabular shell :
  • ,
  • Ceramic acetabular liner :
  • ,
  • Femoral head/stem prosthesis adaptor :
  • ,
  • Bipolar femoral head outer component, hemiarthroplasty :
  • ,
  • Acetabulum prosthesis hole plug :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Orthopaedic chisel :
  • ,
  • Instrument tray, reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Orthopaedic prosthesis implantation instrument, reusable :
  • ,
  • Bone awl :
  • ,
  • Surgical mallet :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Bone-resection orthopaedic reamer, reusable :
  • ,
  • Surgical implant template, reusable :
  • ,
  • Orthopaedic implant aiming arm :
  • ,
  • Orthopaedic implant aiming/guiding block, reusable :
  • ,
  • Orthopaedic fixation implant alignment tool :
  • ,
  • Orthopaedic implant inserter/extractor, reusable :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • Surgical depth gauge, reusable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Joint prosthesis implantation kit, reusable :
  • ,
  • Surgical saw blade, reciprocating, reusable :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Orthopaedic feeler :
  • ,
  • Knee femur prosthesis trial :
  • ,
  • Knee tibia prosthesis trial :
  • ,
  • Orthopaedic bone screw, non-bioabsorbable, sterile :
  • ,
  • Acetabulum prosthesis trial, prefabricated, reusable :
  • ,
  • Bone file/rasp, manual, reusable :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Cannulated surgical drill bit, reusable :
  • ,
  • Sterilization/disinfection container, reusable :
  • ,
  • Bone curette, reusable :
  • ,
  • Acetabular orthopaedic reamer :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Bone lever/elevator :
  • ,
  • Medullary canal orthopaedic reamer, flexible :
  • ,
  • Orthopaedic osteotome blade, reusable :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Orthopaedic trocar blade, reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder, reusable :
  • ,
  • Orthopaedic implantation hammering attachment :
  • ,
  • Orthopaedic implant/instrument adaptor, reusable :
  • ,
  • Orthopaedic surgical distractor, internal :
  • ,
  • Femoral head prosthesis trial :
  • ,
  • Femoral stem prosthesis trial :
  • ,
  • Surgical torque wrench, reusable :
  • ,
  • Bone cutter :
  • ,
  • Surgical gouge :
  • ,
  • Orthopaedic broach :
  • ,
  • General-purpose surgical scissors, reusable :
  • ,
  • Medullary canal orthopaedic reamer, rigid :
  • ,
  • Hand-held surgical retractor, reusable :
  • ,
  • Orthopaedic implant/instrument assembling device :
  • ,
  • Surgical implant handling forceps :
  • ,
  • Ankle binder, reusable :
  • ,
  • Leg procedure positioner :
Biometrics LtdUnits 25-26 Nine Mile Point Industrial Estate

Newport
NP11 7HZ

United Kingdom








08/25/996924
  • Electronic torsional hand exerciser :
  • ,
  • Hand dynamometer/pinchmeter, electronic :
  • ,
  • Biomechanical function analysis/interactive rehabilitation system :
  • ,
  • Biomechanical function analysis/rehabilitation software :
  • ,
  • Medical networking interface unit :
  • ,
  • Electronic goniometer/kinesiology sensor :
  • ,
  • Electromyograph :
  • ,
  • Electromyography telemetric monitoring system transmitter :
  • ,
  • Posturography system :
  • ,
  • Back/leg/chest dynamometer, electronic :
  • ,
  • Posturography system platform :
  • ,
  • Kinesiology/electromyographic sensor set :
Biomimetics Health Industries (UK) LtdSalvox Campus Puckshipton Beechingstoke

Pewsey
Wiltshire SN9 6HG

United Kingdom








05/19/20112118
  • Instrument Cleaning Solutions/Wipes (Non-Disinfecting) :
  • ,
  • Dental Unit Accessories :
  • ,
  • Adhesive Plasters/Dressings/Tapes/Barrier Films :
  • ,
  • Orthopaedic Support Devices :
BioMin Technologies LtdE204 Queens Building QMUL
Mile End
London
E1 4NS

England United Kingdom








01/05/202111373
  • Dentifrice :
bionanovate limitedstudio 9 thegreenhouse Mannings Heath Road

POOLE
Dorset BH12 4NQ

England United Kingdom








03/19/202112794
  • Nasal irrigation saline solution, non-sterile :
  • ,
  • Eyelid solution :
  • ,
  • Nail fungus treatment kit, medicated :
  • ,
  • Superficial skin exfoliant, home-use :
BIONEER Corporation8-11 Munpyeongseo-ro

Daedeok-gu
Daejeon 34302

South Korea

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

Oxford
OX1 2EP

England United Kingdom
020 7193 9185
office@kingsmead-service.com
01/18/202213753
  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated :
  • ,
  • Nucleic acid sample preparation instrument IVD, automated :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • SARS-CoV-2/Influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT) :
Bioness Inc.25103 Rye Canyon Loop

Valencia
California 91355

United States

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

Cambridge
CB24 9BZ

England United Kingdom

11/08/202119567
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
  • ,
  • Gait-enhancement electrical stimulation system, external :
Bioness25103 Rye Canyon Loop

Valencia
CA 91355

United States

P14 Medical LtdUK Responsible Person65 Bath Road

Stroud
Gloucestershire GL5 3LA

England United Kingdom

01/08/202111430
  • Analgesic implantable peripheral nerve electrical stimulation system :
  • ,
  • Tibial nerve implantable incontinence-control electrical stimulation system :
Bionic Medizintechnik GmbHMax-Planck-Strasse 21

Friedrichsdorf
61381

Germany

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom

07/20/202116042
  • Haemodialysis needle :
Bionostics Inc7 Jackson Road

Devens
Massachusetts 01434

United States

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE

England United Kingdom

01/07/202221700
  • :
Bionote Inc.22 Samsung 1-ro 4-gil

Hwaseong-si
Gyeonggi-do 18449

South Korea

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

Oxford
OX1 2EP

England United Kingdom

06/22/202115246
  • SARS-CoV-2 antigen IVD, control :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control :
  • ,
  • SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid :
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom








03/02/20209656
  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • T-cell activation/stimulated interferon release IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Adenovirus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Chikungunya virus immunoglobulin M (IgM) antibody IVD, kit, immunochromatographic (ICT), rapid :
  • ,
  • Clostridium difficile antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Dengue virus antigen/antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Dengue virus antigen IVD, reagent :
  • ,
  • Neisseria gonorrhoeae antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA), rapid :
  • ,
  • Hepatitis E virus total antibody IVD, reagent :
  • ,
  • Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Fluorescent immunoassay analyser IVD, point-of-care, battery-powered :
  • ,
  • Glycated haemoglobin (HbA1C) analyser IVD :
  • ,
  • Troponin I IVD, kit, fluorescent immunoassay :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay :
  • ,
  • Fatty acid binding protein (FABP) IVD, reagent :
  • ,
  • Myoglobin IVD, kit, fluorescent immunoassay :
  • ,
  • C-reactive protein (CRP) IVD, kit, fluorescent immunoassay :
  • ,
  • Procalcitonin (PCT) IVD, kit, fluorescent immunoassay :
  • ,
  • D-dimer IVD, kit, fluorescent immunoassay :
  • ,
  • Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay :
  • ,
  • Microalbumin IVD, reagent :
  • ,
  • Cystatin C IVD, reagent :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay :
  • ,
  • Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay :
  • ,
  • Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay :
  • ,
  • Troponin I IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Troponin T IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test :
  • ,
  • Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Plasmodium falciparum antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Plasmodium vivax antigen IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Plasmodium malariae antigen IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Salmonella typhi immunoglobulin G (IgG)/IgM antibody IVD, reagent :
  • ,
  • Salmonella typhi antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Yersinia pseudotuberculosis total antibody IVD, reagent :
  • ,
  • Urine bilirubin IVD, kit, colorimetric dipstick, rapid :
  • ,
  • Microalbumin IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Rheumatoid factor IVD, reagent :
  • ,
  • Procalcitonin (PCT) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • C-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Serum amyloid A IVD, reagent :
  • ,
  • D-dimer IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Alpha-fetoprotein (AFP) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Cancer antigen 125 (CA125) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Carcinoembryonic antigen (CEA) IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Total haemoglobin (totHb) IVD, reagent :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, immunochromatographic test (ICT) rapid :
  • ,
  • Myoglobin IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, reagent :
  • ,
  • Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, reagent :
  • ,
  • Norovirus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Rotavirus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, reagent :
  • ,
  • Sperm concentration indicator IVD, kit, immunochromatographic test (ICT), self-testing :
  • ,
  • Thyroid stimulating hormone (TSH) IVD, kit, immunochromatographic test (ICT), self-testing :
  • ,
  • Ferritin IVD, kit, immunochromatographic test (ICT), self-testing :
  • ,
  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent :
  • ,
  • SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple helminth immunoglobulin G (IgG) antibody IVD, reagent :
  • ,
  • Giardia lamblia antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Legionella pneumophila antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Mycoplasma pneumoniae IgM antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test :
  • ,
  • Streptococcus pneumoniae antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test :
  • ,
  • Calprotectin IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid :
BIOPLAX LIMITEDENDEAVOUR HOUSE - 78 STAFFORD ROAD

WALLINGTON
SURREY SM6 9AY

England United Kingdom








06/03/202115153
  • :
Bioplus co.Ltd#211 Migun Techno World 2 187 Techno 2-ro
Yuseong-gu
Daejeon
34025

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom

05/14/202114682
  • Surgical anti-adhesion material, implantable, bioabsorbable :
  • ,
  • Dermal tissue reconstructive material, microbe-derived :
BioPolymer GmH & Co. KGWalsmuhler Strasse 18

Dummer
D-19073

Germany

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

Cambridge
CB24 9BZ

England United Kingdom

05/08/202114480
  • Dermal tissue reconstructive material, microbe-derived, anaesthetic :
  • ,
  • Synovial fluid supplementation medium :
BioPro Inc2929 Lapeer Rd

Port Huron
Michigan 48060

United States

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

Cambridge
CB24 9BZ

England United Kingdom

11/11/202119164
  • Bone file/rasp, manual, reusable :
  • ,
  • Orthopaedic osteotome blade, single-use :
  • ,
  • Fluted surgical drill bit, reusable :
BioPro Inc2929 Lapeer Rd

Port Huron
Michigan 48060

United States

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

Cambridge
CB24 9BZ

England United Kingdom

01/13/202221231
  • :
BioProtect Limited8 Tsor Street

Tzur Yigal
4486200

Israel

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom

04/15/202113376
  • Radiotherapy protection spacer :
BiopSafe ApSCarolinevej 2A

Hellerup
2900

Denmark

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH

England United Kingdom

01/14/202221274
  • :
Biopsybell S.R.LVia Aldo Manuzio n. 24

Mirandola
MO 41037

Italy

QCS International LTD.UK Responsible PersonSuite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ

Scotland United Kingdom
'+44(33)33031126
05/19/202114792
  • Vertebral bone biopsy procedure kit, single-use :
  • ,
  • Orthopaedic cement preparation/delivery kit :
  • ,
  • Inflatable bone tamp :
  • ,
  • Bone access channel kit :
  • ,
  • Vertebral body cement cannula :
  • ,
  • Percussion hammer, manual :
  • ,
  • Bone graft syringe, single-use :
  • ,
  • Balloon kyphoplasty kit :
  • ,
  • Stromal vascular fraction recovery set :
  • ,
  • Bone marrow explant needle :
Biorad Medisys Pvt LtdSurvey No.: 48/3 &48/7 Pashan Sus Road Sus Village Taluka Mulshi Pune - 411021 Maharashtra INDIA

Pune
Maharashtra 411021

India

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

London
W1H 1PJ

United Kingdom

11/05/202119786
  • Assisted reproduction transfer catheter/set :
  • ,
  • Nephrostomy catheter :
  • ,
  • Suprapubic drainage catheter :
  • ,
  • Ureteral catheter :
  • ,
  • Endoscopic-access dilator, single-use :
  • ,
  • Fascial tissue dilator, single-use :
  • ,
  • Polymeric ureteral stent :
  • ,
  • Gastro-urological guidewire, single-use :
  • ,
  • Nephrostomy catheter introduction needle :
  • ,
  • Body aspiration needle, single-use :
  • ,
  • Biliary/urinary stone retrieval basket, single-use :
  • ,
  • Luer/Luer linear connector, single-use :
  • ,
  • Incontinence penis clamp, single-use :
  • ,
  • Bladder evacuator, single-use :
  • ,
  • Endoscopic electrosurgical electrode, bipolar, single-use :
  • ,
  • Endoscopic electrosurgical electrode, monopolar, single-use :
BioRegen Biomedical (Changzhou) Co. Ltd.Building B No. 117 Xueye Road

Changzhou
Jiangsu 213125

China

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

Newcastle Upon Tyne
NE16 3DA

United Kingdom

10/26/202118586
  • Suction/irrigation tubing, single-use :
  • ,
  • Wound hydrogel dressing, non-antimicrobial :
Bioretec LtdYrittajankulma 5 FL-33710 Tamperer

Tamperer
Finland FL 77720

Finland

Int2med ltd UK Responsible PersonSuite 1 Unit A1 Tectonic Place Holyport Road
Berks SL6 2YE
Maidenhead
sl6 2ye

United Kingdom

03/10/202112588
  • Orthopaedic bone pin, bioabsorbable :
Bioretec LtdYrittajankulma 5 33710 Tempere
Finland
Tamperer
FL-33710

Finland

Int2med ltd UK Responsible PersonSuite 1 Unit A1 Tectonic Place Holyport Road
Berks SL6 2YE
Maidenhead
sl6 2ye

United Kingdom

03/11/202112622
  • Orthopaedic bone screw, bioabsorbable :
  • ,
  • Orthopaedic surgical procedure kit, non-medicated, single-use :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Bone tap, reusable :
  • ,
  • Fluted surgical drill bit, reusable :
  • ,
  • General internal orthopaedic fixation system implantation kit :
  • ,
  • Surgical countersink, reusable :
  • ,
  • Medullary canal orthopaedic reamer, flexible :
  • ,
  • Bioabsorbable long bone nail :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Surgical drill guide, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Orthopaedic bone screw starter/notcher :
  • ,
  • Surgical instrument/implant rack :
  • ,
  • Orthopaedic implant inserter/extractor, reusable :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Orthopaedic implantation sleeve, reusable :
  • ,
  • Manual surgical rotary handpiece, reusable :
  • ,
  • Surgical depth gauge, reusable :
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom








05/01/20157201
  • Syphilis Antigen Detection :
  • ,
  • TDM/Drug Standards / Calibrators :
  • ,
  • TDM/Drug Controls :
  • ,
  • SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Total bilirubin IVD, control :
  • ,
  • Multiple coagulation factor IVD, control :
  • ,
  • Calcium chloride coagulation reagent IVD :
  • ,
  • Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Haematological cell analyser IVD, automated :
  • ,
  • Treponema pallidum total antibody IVD, control :
  • ,
  • 1,25-Dihydroxy vitamin D3 IVD, control :
  • ,
  • Superoxide dismutase (SOD) IVD, control :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD, calibrator :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD, control :
  • ,
  • Lipoprotein A IVD, calibrator :
  • ,
  • Non-esterified fatty acid IVD, control :
  • ,
  • Total bilirubin IVD, calibrator :
  • ,
  • C-reactive protein (CRP) IVD, calibrator :
  • ,
  • C-reactive protein (CRP) IVD, control :
  • ,
  • Citrate IVD, calibrator :
  • ,
  • Citrate IVD, control :
  • ,
  • Ferritin IVD, calibrator :
  • ,
  • Ferritin IVD, control :
  • ,
  • Retinol binding protein IVD, control :
  • ,
  • Rheumatoid factor IVD, calibrator :
  • ,
  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent :
  • ,
  • Superoxide dismutase (SOD) IVD, reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD, control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator :
  • ,
  • Total cholesterol lipid IVD, control :
  • ,
  • Multiple immunohaematology test IVD, control :
  • ,
  • Aldolase IVD, calibrator :
  • ,
  • Aldolase IVD, control :
  • ,
  • Adenosine deaminase (ADA) IVD, calibrator :
  • ,
  • Adenosine deaminase (ADA) IVD, control :
  • ,
  • Angiotensin converting enzyme (ACE) IVD, calibrator :
  • ,
  • Angiotensin converting enzyme (ACE) IVD, control :
  • ,
  • Anti-A1 red blood cell grouping IVD, lectin :
  • ,
  • Zinc IVD, calibrator :
  • ,
  • Troponin I IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple cardiac marker IVD, control :
  • ,
  • D-dimer IVD, kit, agglutination :
  • ,
  • D-dimer IVD, control :
  • ,
  • D-dimer IVD, calibrator :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD, calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD, control :
  • ,
  • Cystatin C IVD, calibrator :
  • ,
  • Cystatin C IVD, control :
  • ,
  • Cystatin C IVD, kit, nephelometry/turbidimetry :
  • ,
  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Hepatitis G virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Dengue virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple febrile infection-associated bacteria antigen IVD, kit, agglutination :
  • ,
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Mycobacterium tuberculosis complex species antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Multiple Rickettsia species (spotted fever group) total antibody IVD, kit, agglutination :
  • ,
  • Multiple Salmonella species total antibody IVD, kit, agglutination :
  • ,
  • Salmonella paratyphi total antibody IVD, kit, agglutination :
  • ,
  • Salmonella typhi total antibody IVD, kit, agglutination :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent :
  • ,
  • Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum total antibody IVD, kit, agglutination :
  • ,
  • Treponema pallidum total antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Treponema pallidum reagin antibody IVD, kit, agglutination :
  • ,
  • Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Plasmodium falciparum antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Anti-H red blood cell grouping IVD, lectin :
  • ,
  • Anti-Le^a red blood cell grouping IVD, antibody :
  • ,
  • Anti-Le^b red blood cell grouping IVD, antibody :
  • ,
  • Anti-Lu^a red blood cell grouping IVD, antibody :
  • ,
  • Anti-Lu^b 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 :
  • ,
  • ABO multiple blood grouping IVD, kit, agglutination :
  • ,
  • Bovine serum albumin (BSA) immunohaematology reagent IVD :
  • ,
  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD :
  • ,
  • Polyspecific antihuman globulin/complement IVD, antibody :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator :
  • ,
  • Multiple electrolyte IVD, calibrator :
  • ,
  • Multiple electrolyte IVD, control :
  • ,
  • Calcium (Ca2+) IVD, reagent :
  • ,
  • Chloride (Cl-) IVD, reagent :
  • ,
  • Magnesium (Mg2+) IVD, reagent :
  • ,
  • Inorganic phosphate (PO43-) IVD, reagent :
  • ,
  • Potassium (K+) IVD, reagent :
  • ,
  • Sodium (Na+) IVD, reagent :
  • ,
  • Acid phosphatase isoenzyme IVD, reagent :
  • ,
  • Alanine aminotransferase (ALT) IVD, reagent :
  • ,
  • Aldolase IVD, reagent :
  • ,
  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent :
  • ,
  • Total amylase IVD, reagent :
  • ,
  • Angiotensin converting enzyme (ACE) IVD, kit, enzyme spectrophotometry :
  • ,
  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent :
  • ,
  • Pseudocholinesterase IVD, reagent :
  • ,
  • Total creatine kinase (CK) IVD, reagent :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD, reagent :
  • ,
  • Beta-hydroxybutyrate dehydrogenase IVD, reagent :
  • ,
  • Total lactate dehydrogenase (LDH) IVD, reagent :
  • ,
  • Lipase IVD, calibrator :
  • ,
  • Lipase IVD, reagent :
  • ,
  • Ammonia IVD, kit, enzyme spectrophotometry :
  • ,
  • Ammonia IVD, calibrator :
  • ,
  • Ammonia IVD, control :
  • ,
  • Total bilirubin IVD, reagent :
  • ,
  • Creatinine IVD, reagent :
  • ,
  • Fructosamine IVD, calibrator :
  • ,
  • Fructosamine IVD, control :
  • ,
  • Fructosamine IVD, reagent :
  • ,
  • Glucose IVD, reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD, calibrator :
  • ,
  • Glycated haemoglobin (HbA1c) IVD, reagent :
  • ,
  • Lactate IVD, reagent :
  • ,
  • Multiple lipid analyte IVD, calibrator :
  • ,
  • Total cholesterol lipid IVD, reagent :
  • ,
  • Non-esterified fatty acid IVD, reagent :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD, reagent :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD, reagent :
  • ,
  • Lipoprotein A IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein A-II (Apo A2) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein C-II (Apo C2) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein C-III (Apo C3) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Apolipoprotein E (Apo E) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Triglyceride IVD, reagent :
  • ,
  • Microalbumin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Microalbumin IVD, calibrator :
  • ,
  • Microalbumin IVD, control :
  • ,
  • Oxalate IVD, calibrator :
  • ,
  • Oxalate IVD, control :
  • ,
  • Oxalate IVD, reagent :
  • ,
  • Prostacyclin IVD, kit, radioimmunoassay :
  • ,
  • Uric acid IVD, reagent :
  • ,
  • Urea IVD, reagent :
  • ,
  • Multiple clinical chemistry protein IVD, calibrator :
  • ,
  • Multiple clinical chemistry protein IVD, reagent :
  • ,
  • Albumin IVD, reagent :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent :
  • ,
  • Ceruloplasmin IVD, reagent :
  • ,
  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry :
  • ,
  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry :
  • ,
  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Ferritin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Haptoglobin IVD, reagent :
  • ,
  • Homocysteine IVD, calibrator :
  • ,
  • Homocysteine IVD, control :
  • ,
  • Homocysteine IVD, reagent :
  • ,
  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD, reagent :
  • ,
  • Total iron binding capacity IVD (TIBC), reagent :
  • ,
  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Myoglobin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Myoglobin IVD, reagent :
  • ,
  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Total protein IVD, reagent :
  • ,
  • Troponin T IVD, control :
  • ,
  • Troponin I IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Troponin I IVD, calibrator :
  • ,
  • Troponin I IVD, control :
  • ,
  • Troponin I IVD, reagent :
  • ,
  • Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free testosterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Insulin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, fluorescence immunoassay :
  • ,
  • Progesterone IVD, kit, chemiluminescent immunoassay :
  • ,
  • Progesterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Prolactin IVD, kit, chemiluminescent immunoassay :
  • ,
  • Prolactin IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD, calibrator :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD, control :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD, reagent :
  • ,
  • Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Copper IVD, reagent :
  • ,
  • Iron IVD, reagent :
  • ,
  • Zinc IVD, reagent :
  • ,
  • Rheumatoid factor IVD, kit, nephelometry/turbidimetry :
  • ,
  • Rheumatoid factor IVD, kit, agglutination :
  • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple-therapy therapeutic drug monitoring IVD, control :
  • ,
  • Gentamicin therapeutic drug monitoring IVD, reagent :
  • ,
  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Digoxin therapeutic drug monitoring IVD, reagent :
  • ,
  • Carbamazepine therapeutic drug monitoring IVD, reagent :
  • ,
  • Lithium therapeutic drug monitoring IVD, reagent :
  • ,
  • Phenobarbital therapeutic drug monitoring IVD, reagent :
  • ,
  • Phenytoin therapeutic drug monitoring IVD, reagent :
  • ,
  • Valproic acid therapeutic drug monitoring IVD, reagent :
  • ,
  • Multiple drugs of abuse IVD, control :
  • ,
  • Amphetamine/methamphetamine group IVD, reagent :
  • ,
  • Barbiturate IVD, reagent :
  • ,
  • Cannabinoid IVD, reagent :
  • ,
  • Cocaine/cocaine metabolite IVD, reagent :
  • ,
  • Ethanol (ETOH) IVD, reagent :
  • ,
  • Methadone IVD, reagent :
  • ,
  • Methanol IVD, reagent :
  • ,
  • Opiate/opiate metabolite IVD, reagent :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent :
  • ,
  • Erythrocyte sedimentation rate (ESR) IVD, control :
  • ,
  • Activated partial thromboplastin time (APTT) IVD, reagent :
  • ,
  • Prothrombin time (PT) IVD, kit, clotting :
  • ,
  • Thrombin time (TT) IVD, kit, clotting :
  • ,
  • Fibrinogen assay (factor I) IVD, kit, clotting :
  • ,
  • Coagulation factor II (prothrombin) IVD, reagent :
  • ,
  • Coagulation factor V IVD, reagent :
  • ,
  • Coagulation factor VIII IVD, reagent :
  • ,
  • Coagulation factor X IVD, reagent :
  • ,
  • Coagulation factor XI IVD, reagent :
  • ,
  • Coagulation factor XII IVD, reagent :
  • ,
  • Lupus anticoagulant marker IVD, reagent :
  • ,
  • Coagulation factor VII IVD, reagent :
  • ,
  • Coagulation factor IX IVD, reagent :
  • ,
  • Fibrinogen degradation product (FDP) IVD, kit, agglutination :
  • ,
  • Multiple clinical chemistry analyser IVD, laboratory, automated :
  • ,
  • Multiple clinical chemistry analyser IVD, laboratory, semi-automated :
  • ,
  • Ion-selective analyser IVD, automated :
  • ,
  • Coagulation analyser IVD, laboratory, automated :
  • ,
  • Coagulation analyser IVD, laboratory, semi-automated :
  • ,
  • Chemiluminescent immunoassay analyser IVD, semi-automated :
  • ,
  • Enzyme immunoassay (EIA) analyser IVD, automated :
  • ,
  • Citrate IVD, kit, enzyme spectrophotometry :
  • ,
  • Optical instrument performance standard calibrator/control IVD, reusable :
  • ,
  • Total bile acid IVD, reagent :
  • ,
  • Unsaturated iron binding capacity (UIBC) IVD, reagent :
  • ,
  • Buffered wash solution IVD, automated/semi-automated system :
  • ,
  • Buffered sample diluent IVD, automated/semi-automated system :
  • ,
  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Minichromosome maintenance protein 5 (MCM5) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Transferrin IVD, kit, nephelometry/turbidimetry :
  • ,
  • Multiple apolipoprotein IVD, calibrator :
  • ,
  • Red cell antibody diluent IVD, reagent :
  • ,
  • Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Ion selective electrode (ISE) reference solution IVD, reagent :
  • ,
  • Calcium (Ca2+) electrode IVD :
  • ,
  • Chloride (Cl-) electrode IVD :
  • ,
  • Reference electrode IVD :
  • ,
  • Hydrogen (H+)/pH electrode IVD :
  • ,
  • Potassium (K+) electrode IVD :
  • ,
  • Sodium (Na+) electrode IVD :
  • ,
  • Inherited haemoglobinopathy IVD, control :
  • ,
  • Antioxidant capacity IVD, calibrator :
  • ,
  • Antioxidant capacity IVD, control :
  • ,
  • Antioxidant capacity IVD, reagent :
  • ,
  • Carbon dioxide (CO2) IVD, kit, spectrophotometry :
  • ,
  • Carbon dioxide (CO2) IVD, calibrator :
  • ,
  • Carbon dioxide (CO2) IVD, control :
  • ,
  • Vitamin B12 IVD, kit, chemiluminescent immunoassay :
  • ,
  • Total testosterone IVD, kit, chemiluminescent immunoassay :
  • ,
  • Multiple cardiac marker IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Glutamate IVD, reagent :
  • ,
  • Benzodiazepine group therapeutic drug monitoring IVD, reagent :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, chemiluminescent immunoassay :
  • ,
  • Antithrombin III (ATIII) IVD, kit, nephelometry/turbidimetry :
  • ,
  • Total cortisol IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species total antibody IVD, kit, agglutination :
  • ,
  • C-reactive protein (CRP) IVD, kit, agglutination, rapid :
  • ,
  • Brucella abortus total antibody IVD, kit, agglutination :
  • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Brucella melitensis total antibody IVD, kit, agglutination :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, agglutination, rapid :
  • ,
  • Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, agglutination, rapid :
  • ,
  • Multiple Rickettsia species (spotted fever/typhus groups) total antibody IVD, kit, agglutination :
  • ,
  • Orientia tsutsugamushi total antibody IVD, kit, agglutination :
  • ,
  • Glutathione reductase IVD, kit, enzyme spectrophotometry :
  • ,
  • Glutathione reductase IVD, control :
  • ,
  • Glutathione peroxidase IVD, kit, enzyme spectrophotometry :
  • ,
  • Glutathione peroxidase IVD, control :
  • ,
  • Total immunoglobulin E (IgE total) IVD, kit, nephelometry/turbidimetry :
  • ,
  • 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Multiple febrile infection-associated bacteria antibody IVD, control :
  • ,
  • Urine test strip colour chart IVD :
  • ,
  • D-dimer IVD, kit, nephelometry/turbidimetry :
  • ,
  • C-peptide IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Fibrinogen (Factor I) assay IVD, kit, nephelometry/turbidimetry :
  • ,
  • Multiple Plasmodium species antigen IVD, kit, enzyme immunoassay (EIA) :
  • ,
  • Non-immunoglobulin allergic mediator/allergy cell marker reagent IVD :
  • ,
  • Haemoglobin detection IVD, reagent :
  • ,
  • Glycated haemoglobin (HbA1C) analyser IVD :
  • ,
  • Adenosine deaminase (ADA) IVD, reagent :
  • ,
  • Alpha-fetoprotein (AFP) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Carcinoembryonic antigen (CEA) IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • C-reactive protein (CRP) IVD, kit, immunochromatographic test (ICT) :
  • ,
  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test :
  • ,
  • Neisseria gonorrhoeae antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Hepatitis A virus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Salmonella typhi antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • Copper IVD, control :
BIOS Health Ltd.8 Bateman Mews

Cambridge
CB2 1NN

England United Kingdom








04/23/202113763
  • Clinical management support software :
Bios s.r.l.Street & N° Via Guido Rossa 10/12

Vimodrone (MI)
20055

Italy

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR

England United Kingdom

09/24/202117615
  • Radio-frequency skin contouring system :
  • ,
  • Multi-modality skin surface treatment system :
  • ,
  • Multi-modality physical therapy system :
Biosafe S.A.Route du Petit Eysins 1

Eysins
1262

Switzerland

Asymptote Ltd. Part of CytivaUK Responsible PersonSovereign House

Cambridge
CB249BZ

United Kingdom

07/26/202116230
  • Bone marrow collection/transfusion set :
  • ,
  • Cooling laboratory mixer solution transfer tubing :
  • ,
  • Blood centrifugation system processing unit :
  • ,
  • Blood centrifugation system containment kit :
  • ,
  • Blood/tissue storage/culture container :
  • ,
  • Cooling laboratory mixer :
BioScience GmbHWalsmuhler Strasse 18

Dummer
19073

Germany

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

Cambridge
CB24 9BZ

England United Kingdom

05/10/202114586
  • Periodontal tissue reconstructive material :
  • ,
  • Dermal tissue reconstructive material, microbe-derived :
Biosculptor CorporationTrading as: Maramed Orthopedic Systems 2480 West 82nd Street

Hialeah
Florida 33016

United States

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL

United Kingdom

mark.garvey@csamhealth.com
11/18/202119076
  • Cranial orthosis :
  • ,
  • Hand orthosis :
  • ,
  • Wrist/hand/finger extension orthosis :
  • ,
  • Wrist immobilizer, single-use :
  • ,
  • Arm splint system, thermoplastic :
  • ,
  • Leg splint system, thermoplastic :
  • ,
  • Ankle/foot orthosis :
  • ,
  • Upper-limb traction wrap/trap, single-use, non-sterile :
  • ,
  • Stockinette :
BIOSENSE WEBSTER INC.31 TECHNOLOGY DRIVE SUITE 200

IRVINE
CALIFORNIA 92618

United States

Johnson & Johnson Medical LtdUK Responsible PersonBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom

09/22/202117688
  • Intracardiac ultrasound imaging catheter, steerable, single-use :
  • ,
  • Cardiac mapping catheter, percutaneous, single-use :
  • ,
  • Electrical-only medical device connection cable, reusable :
  • ,
  • Cardiac mapping/endocardial-injection catheter :
  • ,
  • Vascular catheter introduction set, nonimplantable :
  • ,
  • Cardiac radio-frequency ablation system catheter :
  • ,
  • Cardiac radio-frequency ablation system generator :
  • ,
  • Radio-frequency ablation system generator :
  • ,
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Surgical irrigation pump :
BIOSENSE WEBSTER INC33 TECHNOLOGY DRIVE

IRVINE
CALIFORNIA 92618

United States

Johnson & Johnson Medical LtdUK Responsible PersonBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom

01/27/202111814
  • Radio-frequency ablation system generator :
  • ,
  • Intracardiac ultrasound imaging catheter, steerable, single-use :
  • ,
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Cardiac mapping system reference patch :
  • ,
  • Cardiac mapping catheter, percutaneous, single-use :
  • ,
  • Electrical-only medical device connection cable, reusable :
  • ,
  • Cardiac mapping/endocardial-injection catheter :
  • ,
  • Vascular catheter introduction set, nonimplantable :
  • ,
  • Cardiac radio-frequency ablation system catheter :
  • ,
  • Cardiac radio-frequency ablation system generator :
Biosense Webster (israel) Ltd4 Hatnufa Street

Yokneam 2066717
2066717

Israel

Johnson & Johnson Medical LtdUK Responsible PersonBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom

01/08/202111397
  • Cardiac mapping system :
Biosensors Europe SARue de Lausanne 29

Morges
1110

Switzerland

BIOSENSORS INTERNATIONAL UK LTDUK Responsible Person12 NEW FETTER LANE

LONDON
EC4A1JP

England United Kingdom

04/26/202113833
  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated :
  • ,
  • Drug-coated-metal coronary artery stent :
  • ,
  • Bare-metal coronary artery stent :
  • ,
  • Coronary angioplasty balloon catheter, basic :
  • ,
  • Coronary angioplasty balloon catheter, drug-coated :
  • ,
  • Peripheral angioplasty balloon catheter, drug-coated :
Biosensors Interventional Technologies Pte. Ltd.36 Jalan Tukang

Singapore
619266

Singapore

BIOSENSORS INTERNATIONAL UK LTDUK Responsible Person12 NEW FETTER LANE

LONDON
EC4A1JP

England United Kingdom

04/19/202113509
  • Coronary angioplasty balloon catheter, basic :
Bioserv UK LimitedSalisbury House Station Road

Cambridge
CB1 2LA

United Kingdom








04/23/20209864
  • Reverse transcription reagent kit IVD :
  • ,
  • General specimen container IVD, preservation solution, sterile :
Biosigma S.p.AVia Valletta 6

Cantarana di Cona
Venice 30010

Italy

Mornington 2000 LLP trading as Sterilab ServicesUK Responsible Person18 Mornington Terrace

Harrogate
North Yorkshire HG1 5DH

England United Kingdom

12/29/202121524
  • :
Biosil Limited127 Deerdykes Way Westfield Industrial Estate

Cumbernauld
Glasgow G68 9HN

United Kingdom








10/27/20145564
  • Adhesive Plasters/Dressings/Tapes/Barrier Films :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Accessories For Implantable Devices (Non-Invasive) :
  • ,
  • Body And Cranio-Maxillofacial Contouring Implants :
Biosphere Medical SAParc des Nations – Paris Nord 2
383 Rue De La Belle Etoile
Roissy-en-France
Val-D'oise 95700

France

Merit Medical UK LimitedUK Responsible PersonUnit 27 Suttons Business Park Sutton Park Avenue Earley Reading Berkshire RG6 1AZ United Kingdom

Reading
Berkshire RG6 1AZ

England United Kingdom

03/19/202112796
  • Chemotherapeutic agent embolization particle :
  • ,
  • Embolization particle, non-bioabsorbable :
  • ,
  • Non-neurovascular embolization plug, animal-derived :
  • ,
  • Vascular guide-catheter, single-use :
  • ,
  • Peripheral vascular guidewire, manual :
BIOSTER a.s.Tejny 621

Veverská Bítýška
66491

Czechia

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ

England United Kingdom

04/27/202113932
  • Plant polysaccharide haemostatic agent, bioabsorbable :
BIOSYNEX SA22 Boulevard Sebastien Brant
ILLKIRCH-GRAFFENSTADEN
Strasbourg
Bas-Rhin 67400

France

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom

06/30/202115647
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Vaginal pH screening IVD, kit, colorimetric dipstick, self-testing :
  • ,
  • Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, immunochromatographic test (ICT), rapid :
BIOSYNEX SWISS SARue De Romont 29-31

Fribourg
La Sarine 1700

Switzerland

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom

06/30/202115648
  • D-dimer IVD, kit, immunochromatographic test (ICT), rapid :
BIOSYSTEMS S.A.Costa Brava 30

Barcelona
08030

Spain

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom

11/30/202120219
  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay :
  • ,
  • Adrenal antibody IVD, kit, fluorescent immunoassay :
  • ,
  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay :
  • ,
  • Islet cell antibody IVD, kit, fluorescent immunoassay :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay :
  • ,
  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay :
  • ,
  • Skin antibody IVD, kit, fluorescent immunoassay :
  • ,
  • Smooth muscle antibody IVD, control :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD, control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD, control :
  • ,
  • Citrate IVD, kit, enzyme spectrophotometry :
  • ,
  • Phosphate buffer/Sorenson buffer solution IVD :
  • ,
  • Human immunoglobulin A (IgA) caprine conjugate antibody reagent IVD :
  • ,
  • Human immunoglobulin G (IgG) caprine conjugate antibody reagent IVD :
  • ,
  • Multiple clinical chemistry analyser IVD, laboratory, automated :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Endomysium antibody (EMA) IVD, control :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD, control :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control :
  • ,
  • Intrinsic factor/parietal cell antibody IVD, control :
Biotec Diagnostics UK LtdUnit 20 Cloud Hill Enterprises Eastcourt Road Temple Cloud

Bristol
Avon BS39 5BX

United Kingdom








03/10/20167215
  • Amylase - Total :
  • ,
  • Angiotensin Converting Enzyme (CC) IC =>12.06.02.03 :
  • ,
  • Aspartate Amino-Transferase :
  • ,
  • Cholinesterase :
  • ,
  • Chymotrypsin :
  • ,
  • Creatine Kinase - MB Activity (CC) IC =>12.01.05.02 :
  • ,
  • Glutamate Dehydrogenase :
  • ,
  • Hydroxybutyrate Dehydrogenase :
  • ,
  • Lactate Dehydrogenase P ( LDH - P --> L ) :
  • ,
  • Lactate Dehydrogenase Isoenzymes :
  • ,
  • Leucine Aminopeptidase :
  • ,
  • Lysozyme :
  • ,
  • Malate Dehydrogenase :
  • ,
  • N-acetyl-?,D-Glucosaminidase :
  • ,
  • Pepsin :
  • ,
  • Phospho Hexose Isomerase :
  • ,
  • Sorbitol Dehydrogenase :
  • ,
  • Other Enzymes :
  • ,
  • Substrates :
  • ,
  • Bile acids :
  • ,
  • Creatinine :
  • ,
  • D-Xylose :
  • ,
  • Non Esterified Fatty Acids :
  • ,
  • Oxalate :
  • ,
  • Phospholipids :
  • ,
  • Porphobilinogen :
  • ,
  • Pyruvate :
  • ,
  • Thymol :
  • ,
  • Total Lipids :
  • ,
  • Total Porphyrine :
  • ,
  • Zinc :
  • ,
  • Lipoprotein Electrophoresis :
  • ,
  • Protein Electrophoresis :
  • ,
  • Phenylketonuria :
  • ,
  • Other Substrates :
  • ,
  • Electrolytes (Reagents) :
  • ,
  • Bicarbonate :
  • ,
  • Chloride :
  • ,
  • Lithium :
  • ,
  • Other Electrolytes :
  • ,
  • Multicomponent Control Sera (Clinical Chemistry) :
  • ,
  • Assayed Multicomponent Sera (CC) :
  • ,
  • Unassayed Multicomponent Sera (CC) :
  • ,
  • Other Multicomponent Sera (CC) :
  • ,
  • Calibrators and Standards (Clinical Chemistry) :
  • ,
  • Calibrators Multicomponent (CC) :
  • ,
  • Calibrators Singlecomponent (CC) :
  • ,
  • Syphilis Antigen Detection :
  • ,
  • Enzymes :
  • ,
  • 5'-Nucleotidase :
  • ,
  • Acid Phosphatase (CC) IC => 12.03.01.37 :
  • ,
  • Aldolase :
  • ,
  • Alkaline Phosphatase Isoenzymes(CC) IC => 12.06.03.01 :
  • ,
  • PSA - Rapid Test :
  • ,
  • Other Tumour Marker Rapid Tests :
  • ,
  • Fertility / Pregnancy Rapid Tests :
  • ,
  • FSH - Rapid Test :
  • ,
  • HCG - Rapid Test :
  • ,
  • HPL - Rapid Test :
  • ,
  • LH - Rapid Test :
  • ,
  • Other Fertility/Pregnancy Rapid Tests :
  • ,
  • Drugs of Abuse/Toxicology Rapid Tests :
  • ,
  • Amphetamines Group - Rapid Test :
  • ,
  • Amphetamines - Rapid Test :
  • ,
  • Barbiturates - Rapid Test :
  • ,
  • Benzodiazepines - Rapid Test :
  • ,
  • Cannabinoids - Rapid Test :
  • ,
  • Cocaine + Cocaine Metabolites - Rapid Test :
  • ,
  • Methadone - Rapid Test :
  • ,
  • Opiates - Rapid Test :
  • ,
  • Phencyclidine - Rapid Test :
  • ,
  • Tricyclic Antidepressants - Rapid Test :
  • ,
  • Multiple Drugs of Abuse/Toxicology Rapid Tests :
  • ,
  • Other Drugs of Abuse/Toxicology Rapid Tests & POC :
  • ,
  • C-Reactive Protein - Rapid Test :
  • ,
  • Other Rheumatoid - Inflammatory Rapid Tests :
  • ,
  • Thyroid Function Hormones :
  • ,
  • Free Triiodothyronine :
  • ,
  • Free Thyroxine :
  • ,
  • Neonatal Thyroid Stimulating Hormone :
  • ,
  • Reverse Triiodothyronine :
  • ,
  • Triiodothyronine :
  • ,
  • Triiodothyronine Uptake :
  • ,
  • Thyroxine :
  • ,
  • Thyroglobulin :
  • ,
  • Thyroid binding globulin :
  • ,
  • Thyroid Stimulating Hormone :
  • ,
  • Neonatal Thyroxine :
  • ,
  • Other thyroid hormones :
  • ,
  • Anemia :
  • ,
  • Erythropoietin :
  • ,
  • Ferritin :
  • ,
  • Folate :
  • ,
  • Iron (IC) CC =>11.02.01.16 :
  • ,
  • Iron Binding Capacity - Total (IC) CC =>11.02.01.17 :
  • ,
  • Other Anemia :
  • ,
  • Rheumatoid Diseases :
  • ,
  • Anti-Streptococcal D Nase B :
  • ,
  • Anti-Streptococcal Hyaluronidase :
  • ,
  • Anti-Streptokinase (ASK) :
  • ,
  • Anti-Streptolysin Reaction /Titre (quantitative) :
  • ,
  • Anti-Streptolysin/Anti-Streptolysin O (qualitative) :
  • ,
  • Anti-Staphylolysin (qualitative) :
  • ,
  • Circulating Immune Complexes :
  • ,
  • Anti-Cyclic Citrullinated Peptide :
  • ,
  • Other Rheumatoid Factors :
  • ,
  • Delta-Aminolaevulinic acid :
  • ,
  • Fructosamine :
  • ,
  • Fructose :
  • ,
  • Galactose :
  • ,
  • Iron (CC) IC =>12.07.01.04 :
  • ,
  • Lecithin :
  • ,
  • Lipoprotein, Chemical determination/detection :
  • ,
  • Low Density Lipoproteins :
  • ,
  • Other Haematology Controls :
  • ,
  • General Coagulation Tests :
  • ,
  • Thrombin Time / Reptilase / Batroxobin Time :
  • ,
  • Activated Clotting Time :
  • ,
  • Other Global Coagulation Tests :
  • ,
  • Coagulation Factors :
  • ,
  • Fibrinogen Assays (Factor I) :
  • ,
  • Coagulation factor II ( Prothrombin ) :
  • ,
  • Coagulation factor II a ( Thrombin ) :
  • ,
  • Coagulation factor V :
  • ,
  • Coagulation factor VII :
  • ,
  • Coagulation factor VII a :
  • ,
  • Coagulation factor VIII :
  • ,
  • Coagulation factor IX :
  • ,
  • Coagulation factor X :
  • ,
  • Coagulation factor XI :
  • ,
  • Coagulation factor XII :
  • ,
  • Aqueous Standards (CC) :
  • ,
  • Clinical Chemistry, Calibrators and Standards, Other Calibrators and Standards :
  • ,
  • Urine Testing (CC) :
  • ,
  • Urine Multi-constituent Test Strips (automated) :
  • ,
  • Urine Testing Calibrator and Control :
  • ,
  • Urine Testing Calibrators and Standards :
  • ,
  • Other Urine Testing :
  • ,
  • Faeces Tests (CC) :
  • ,
  • Faecal Occult Blood (CC) IC =>12.03.90.04 :
  • ,
  • Other Faeces Test :
  • ,
  • Transport Proteins :
  • ,
  • Albumin (IC) CC =>11.02.01.01 :
  • ,
  • Dehydrated Culture Media (Bacteriology) :
  • ,
  • Dehydrated Culture Media (DCM) :
  • ,
  • Raw materials for preparing DCM :
  • ,
  • Additives for DCM :
  • ,
  • Other DCM :
  • ,
  • Stains, Buffers etc (Bacteriology) :
  • ,
  • Gram's Stain :
  • ,
  • Other Stains :
  • ,
  • Miscellaneous Buffers, Controls and Standards :
  • ,
  • Other Detection and Identification (Parasitology) :
  • ,
  • Salmonella Antigen Detection :
  • ,
  • Other Salmonella Reagents :
  • ,
  • Other H. Pylori Reagents :
  • ,
  • Other Syphilis Reagents :
  • ,
  • H. Pylori - Rapid Test :
  • ,
  • Cardiac Markers :
  • ,
  • Reagents for (Automated) Haematology Analyzer :
  • ,
  • CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) :
  • ,
  • Cardiac Markers Rapid Tests :
  • ,
  • CK - MB / Myoglobin - Rapid Test :
  • ,
  • Myoglobin - Rapid Test :
  • ,
  • Troponin I/T - Rapid Test :
  • ,
  • BNP / proBNP - Rapid Test (including other Natriuric Peptides) :
  • ,
  • Heart Type Fatty Acid Binding Protein Rapid Tests :
  • ,
  • Multiple Cardiac Markers :
  • ,
  • Other Cardiac Marker Rapid Tests :
  • ,
  • Standards/Calibrators/Controls/Immunochcem Rapid Test :
  • ,
  • Haematology Stains for Microscopy :
  • ,
  • Histo / Cyto stains :
  • ,
  • Romanowsky stains :
  • ,
  • Other Haematology Stains :
  • ,
  • Other Haematology Testing Reagents :
  • ,
  • Erthythrocyte Sedimentation Rate Test :
  • ,
  • Other Other Haematology Testing Reagents :
  • ,
  • Control Blood Normal :
  • ,
  • Control Blood Multilevel :
  • ,
  • Whole Blood Controls :
  • ,
  • Urine Screening Manual - Dipslides etc.) :
  • ,
  • Other Urine Screening (Bacteriology) :
  • ,
  • Gas generating kits :
  • ,
  • Manual Blood Culture bottles :
  • ,
  • Manual Mycobacteria (Tubes + Bottles) :
  • ,
  • Biochemical Identification - Automated :
  • ,
  • Fatty Acid Binding Protein :
  • ,
  • Troponin (T + I) :
  • ,
  • Homocsyeine :
  • ,
  • High-Sensitivity C-Reactive Protein :
  • ,
  • Other Cardiac Proteins :
  • ,
  • Specific Proteins Rapid Tests (Cardiac Markers) :
  • ,
  • Albumin (IC) inclu. uAlbumin :
  • ,
  • Glycosylated/Glycated Haemoglobin Rapid Test :
  • ,
  • Other Specific Proteins Rapid Tests :
  • ,
  • Tumour Markers Rapid Tests :
  • ,
  • BTA - Rapid Test :
  • ,
  • Fixing reagents (Histology/Cytology) :
  • ,
  • Other Histology / Cytology reagents :
  • ,
  • CH Hardware + accessories + consumables + software :
  • ,
  • IC&II Hardware + accessories + consumables + software :
  • ,
  • IM Hardware + accessories + consumables + software :
  • ,
  • GE Hardware + accessories + consumables + software :
  • ,
  • HPLC Hardware + Accessories + Consumables + Software :
  • ,
  • RT_BGM Hardware + accessories + consumables + software :
  • ,
  • RT_BG POC Hardware + accessories + consumables + software :
  • ,
  • RT_CC Hardware + accessories + consumables + software :
  • ,
  • RT_IC Hardware + accessories + consumables + software :
  • ,
  • RT_CC/IC combined Hardware + acc + consumables + software :
  • ,
  • Other RT_CI Hardware + dedicated accessories + consumables + software :
  • ,
  • POC Blood Gas / Electolytes Hardware + acc + cons + software :
  • ,
  • Other POC Hardware + acc +cons + software :
  • ,
  • Diabetes Management Hardware + dedicated accessories + software :
  • ,
  • CC Hardware + accessories + consumables + software :
  • ,
  • HS Hardware + accessories + consumables + software :
  • ,
  • Coagulation factor XII a :
  • ,
  • Coagulation factor XIII :
  • ,
  • Coagulation factor HMW-Kininogen (Fitzgerald) :
  • ,
  • Coagulation factor von Willebrand :
  • ,
  • Prekallikrein / Kallikrein (Fletcher factor) :
  • ,
  • Coagulation factor von Wille brand RCO :
  • ,
  • Other Coagulation Factors :
  • ,
  • Fibrinolysis :
  • ,
  • D-Dimer :
  • ,
  • Plasmin :
  • ,
  • Plasminogen :
  • ,
  • Other Fibrinolysis Tests :
  • ,
  • Coagulation Inhibitors :
  • ,
  • Antiphosholipid antibodies :
  • ,
  • Antithrombin III :
  • ,
  • Coagulation factor VIII Inhibitor :
  • ,
  • Coagulation factor IX Inhibitor :
  • ,
  • Coagulation factor X Inhibitor :
  • ,
  • Lupus Anticoagulant :
  • ,
  • Protein C :
  • ,
  • APC Resistance :
  • ,
  • Homocysteine IC => 12.13.01.09 :
  • ,
  • Other Coagulation Inhibitors :
  • ,
  • Haemostasis Controls :
  • ,
  • Reference Plasmas :
  • ,
  • Other Haemostasis Controls :
  • ,
  • Other Prepared Media in Plates (Mycology) :
  • ,
  • Tubes and Bottled Media for Yeasts and Fungi :
  • ,
  • Dip Slides (Mycology) :
  • ,
  • Other Tubes Media for yeasts and Fungi :
  • ,
  • Identification (Mycology) :
  • ,
  • Enterobacteriaceae - Automated :
  • ,
  • Streptococci - Automated :
  • ,
  • Anaerobes - Automated :
  • ,
  • Gram Negative Automated Susceptibility Testing :
  • ,
  • Gram Positive Automated Susceptibility Testing :
  • ,
  • Combined Susceptibility & Identification Systems Gram Negatives Automated :
  • ,
  • Combined Susceptibility & Identification Systems Gram Positives Automated :
  • ,
  • Other Automated Identification :
  • ,
  • Other Automated Susceptibility Testing (incl consumables) :
  • ,
  • Biochemical Identification - Manual :
  • ,
  • Enterobacteriaceae - Manual :
  • ,
  • Streptococci - Manual :
  • ,
  • Haemophilus & Neisseria - Manual :
  • ,
  • Mycoplasma - Manual :
  • ,
  • Other Manual Identification (Optichin, Bacitracin etc.) :
  • ,
  • Immunological Identification :
  • ,
  • Streptococci :
  • ,
  • Staphylococci :
  • ,
  • Meningitis Causative Agents :
  • ,
  • Other Immunological Identification :
  • ,
  • MIC Systems - Manual :
  • ,
  • Impregnated Disks, Multi-disks & Tablets :
  • ,
  • Multipoint Systems :
  • ,
  • Other Manual Susceptibility Testing :
  • ,
  • Nucleic Acid Identification - manual / automated MRSA :
  • ,
  • Dehydrated Culture Media (Mycology) :
  • ,
  • DCM for Yeasts and Fungi :
  • ,
  • HC Hardware + accessories + consumables + software :
  • ,
  • Other_HHC Hardware + accessories + consumables + software :
  • ,
  • EP Hardware + accessories + consumables + software :
  • ,
  • POC Blood Gas Hardware + acc + cons + software :
  • ,
  • POC Electolytes Hardware + acc + cons + software :
  • ,
  • Urinary Screening System Hardware + accessories + consumables + software :
  • ,
  • Prepared Media in Tubes (Bacteriology) :
  • ,
  • Broth Media (Tubes) :
  • ,
  • Transport Media (Tubes) :
  • ,
  • Sample transport for NA Testing :
  • ,
  • Other Media in Tubes :
  • ,
  • Prepared Media in Bottles (Bacteriology) :
  • ,
  • Agar Media for Pouring (Bottles) :
  • ,
  • Prepared Media in Plates (Bacteriology) :
  • ,
  • Isolation Media (Plates) :
  • ,
  • Substrate Incorporated ID Media (Plates) :
  • ,
  • Susceptibility Test Media (Plates) :
  • ,
  • Plates for Environmental Testing :
  • ,
  • Other Prepared Media in Plates :
  • ,
  • Urine Screening (Bacteriology) :
  • ,
  • Urine Screening Systems - Automated :
  • ,
  • Urine Screening Manual (Strips etc.) :
  • ,
  • Gonococci detection by NA Reagents :
  • ,
  • Other Gonococci Reagents :
  • ,
  • Syphilis :
  • ,
  • Syphilis Antibody Assays Total :
  • ,
  • Syphilis Antibody IgG :
  • ,
  • Syphilis Antibody IgM :
  • ,
  • Legionella :
  • ,
  • Legionella Antigen Detection :
  • ,
  • Legionella Antibody Assays :
  • ,
  • Identification Systems for Yeasts - Manual :
  • ,
  • Identification Systems for Yeasts and Fungi - Automated :
  • ,
  • Serological Identification (Mycology) :
  • ,
  • Serological Identification of Yeasts and Fungi :
  • ,
  • Susceptibility Testing (Mycology) :
  • ,
  • Susceptibility Testing Systems for Yeasts and Fungi :
  • ,
  • Tissue Culture :
  • ,
  • Media for Tissue Culture :
  • ,
  • Serum for Tissue Culture :
  • ,
  • Other Tissue Culture Additives and Solutions :
  • ,
  • Other Virology ( Microbiology ) Reagents :
  • ,
  • Extraction Reagents :
  • ,
  • Parasitology Extraction Reagents :
  • ,
  • Parasitology Stains :
  • ,
  • Other Parasitology Reagents :
  • ,
  • Serological Detection and Identification (Parasitology) :
  • ,
  • Pneumocystis carinii :
  • ,
  • Plasmodium falciparum :
  • ,
  • Cryptosporidium :
  • ,
  • Controls/Standards/Calibrators - Microbiology :
  • ,
  • QC Strains Bacteriology :
  • ,
  • Other Controls Microbiology :
  • ,
  • Rapid Tests - Microbiology :
  • ,
  • Other Microbiology Rapid Tests :
  • ,
  • Other microbiology reagents :
  • ,
  • Chlamydia :
  • ,
  • Chlamydia Antigen Detection :
  • ,
  • Chlamydia trachomatis Antibody Assays Total :
  • ,
  • Chlamydia Antibody IgA :
  • ,
  • Chlamydia Antibody IgG :
  • ,
  • Legionella Detection by NA Reagents :
  • ,
  • Other Legionella Reagents :
  • ,
  • Lyme Borreliosis :
  • ,
  • Lyme Antigen Detection :
  • ,
  • Lyme Antibody Total :
  • ,
  • Lyme Antibody IgG :
  • ,
  • Lyme Antibody IgM :
  • ,
  • Other Lyme Borelliosis Reagents :
  • ,
  • Mycobacteria genus + species :
  • ,
  • Mycobacterial Antigen Detection :
  • ,
  • Mycobacterial Antibody Assays :
  • ,
  • Mycobacterial Detection by NA Reagents :
  • ,
  • Other Mycobacteria Reagents :
  • ,
  • Mycoplasma :
  • ,
  • Mycoplasma Antigen Detection :
  • ,
  • Mycoplasma Antibody Assays :
  • ,
  • Mycoplasma Detection by NA Reagents :
  • ,
  • Other Mycoplasma Reagents :
  • ,
  • Pseudomonas Aeruginosa :
  • ,
  • Pseudomonas Aeruginosa Antibody IgG :
  • ,
  • Other Pseudomonas Aeruginosa Reagents :
  • ,
  • Streptococcal Direct Antigen Detection :
  • ,
  • Streptococci Detection by NA Reagents :
  • ,
  • Strep. A Detection by NA Reagents NA Identification (Bacteriology) - VRE => 14.02.40.04 :
  • ,
  • Strep. B Detection by NA Reagents NA Identification (Bacteriology) - VRE => 14.02.40.04 :
  • ,
  • Other Streptococci Reagents :
  • ,
  • Staphylococcal Direct Antigen Detection :
  • ,
  • Staphylococci Detection by NA Reagents :
  • ,
  • Other Staphylococci Reagents :
  • ,
  • Listeria :
  • ,
  • Chlamydia Antibody IgM :
  • ,
  • Chlamydia Detection by NA Reagents :
  • ,
  • Other Chlamydia Reagents :
  • ,
  • Gonococci :
  • ,
  • Gonococcal Antigen Detection :
  • ,
  • Gonococcal Antibody Assays Total :
  • ,
  • Prepared Media in Plates (Mycology) :
  • ,
  • PPM for Yeasts and Fungi :
  • ,
  • Substrate Incorporated Media for Yeasts and Fungi :
  • ,
  • Other Listeria Reagents :
  • ,
  • Camphylooacter Direct Antigen Detection :
  • ,
  • Campylobacter Detection by NA Reagents :
  • ,
  • Other Campylobacter Reagents :
  • ,
  • E Coli Direct Antigen Detection :
  • ,
  • E. coli Detection by NA Reagents :
  • ,
  • Other E Coli Reagents :
  • ,
  • Listeria Antigen Detection :
  • ,
  • Listeria Antibody Assays :
  • ,
  • Listeria Monocytogenes Antibody Assays :
  • ,
  • Listeria Detection by NA Reagents :
  • ,
  • Reticulocyte reagents :
  • ,
  • Other Reagents for (Automated) Haematology Analyzer :
  • ,
  • Haemoglobin (Types) Testing :
  • ,
  • Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) :
  • ,
  • Other Haemoglobin Testing :
  • ,
  • Albumin in stool (Meconium) :
  • ,
  • Reticulocyte Haemoglobin Content :
  • ,
  • Anti-Streptococcal Screening :
  • ,
  • Theophylline - RT & POC :
  • ,
  • Other TDM RT & POC :
  • ,
  • Controls Immunochem - RT & POC :
  • ,
  • Controls, Standards and Calibrators Immunochem - RT & POC :
  • ,
  • Platelet Controls :
  • ,
  • Reticulocyte Controls :
  • ,
  • Coagulation factor von Willebrand Collagen Binding Assay (CBA) :
  • ,
  • Heparin Cofactor II - Tissue Factor Pathway Inhibitor :
  • ,
  • Pro C Global :
  • ,
  • Free Protein S Antigen :
  • ,
  • Total Protein S Antigen :
  • ,
  • Protein S Activity :
  • ,
  • Therapeutic Drug Monitoring (TDM) RT & POC :
  • ,
  • Rheumatoid / Inflammatory Disease RT & POC :
  • ,
  • Haematology Controls and Calibrators :
  • ,
  • ABO multiple blood grouping IVD, kit, agglutination :
  • ,
  • Activated partial thromboplastin time (APTT) IVD, reagent :
  • ,
  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent :
  • ,
  • Albumin/creatinine ratio (ACR) IVD, reagent :
  • ,
  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent :
  • ,
  • Ammonia IVD, reagent :
  • ,
  • Amylase isoenzyme IVD, reagent :
  • ,
  • Staphylococcus aureus staphylolysin total antibody IVD, reagent :
  • ,
  • Conjugated (direct) bilirubin IVD, reagent :
  • ,
  • Urea IVD, reagent :
  • ,
  • Brucella abortus total antibody IVD, kit, agglutination :
  • ,
  • Calcium (Ca2+) IVD, reagent :
  • ,
  • Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVD :
  • ,
  • Total cholesterol lipid IVD, reagent :
  • ,
  • Immunohistochemistry negative control (normal animal serum) IVD :
  • ,
  • Plasma cell IVD, control :
  • ,
  • Copper IVD, reagent :
  • ,
  • C-reactive protein (CRP) IVD, reagent :
  • ,
  • Creatine kinase (CK) multiple isoenzyme IVD, reagent :
  • ,
  • Creatine kinase (CK) multiple isoenzyme IVD, control :
  • ,
  • Creatinine IVD, reagent :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD, reagent :
  • ,
  • Glucose IVD, reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD, reagent :
  • ,
  • Total haemoglobin (totHb) IVD, control :
  • ,
  • Glucose/haemoglobin (Hb) IVD, reagent :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD, reagent :
  • ,
  • Total iron binding capacity IVD (TIBC), reagent :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD, reagent :
  • ,
  • Lactate dehydrogenase (LDH) liver isoenzyme IVD, reagent :
  • ,
  • Lipase IVD, reagent :
  • ,
  • Magnesium (Mg2+) IVD, reagent :
  • ,
  • Inorganic phosphate (PO43-) IVD, reagent :
  • ,
  • Potassium (K+) IVD, reagent :
  • ,
  • Prothrombin time (PT) IVD, reagent :
  • ,
  • Oxidase production microbial reagent IVD :
  • ,
  • Rheumatoid factor IVD, reagent :
  • ,
  • Multiple Salmonella species culture isolate antigen IVD, reagent :
  • ,
  • Sodium (Na+) IVD, reagent :
  • ,
  • Antibacterial susceptibility testing disc IVD :
  • ,
  • Total protein IVD, reagent :
  • ,
  • Triglyceride IVD, reagent :
  • ,
  • Uric acid IVD, reagent :
  • ,
  • Multiple urine analyte IVD, control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent :
BIOTEC ITALIA S.R.L.Viale della Repubblica

DUEVILLE (VI)
20 - 36031

Italy

BIOTEC ITALIA UK LIMITEDUK Responsible PersonCity Cas Room 540 Linen Hall 162 - 168 Regents Street

London
England W1B 5TF

England United Kingdom

01/10/202221139
  • :
BIOTEC s.r.l.Via Industria 53

Povolaro di Dueville
Vicenza 36031

Italy

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom

rebecca.tansley@whi.consulting
11/05/202119856
  • Bone trephine :
  • ,
  • Surgical countersink, reusable :
  • ,
  • Synthetic bone graft :
  • ,
  • Bone tap, reusable :
  • ,
  • Dental implantation depth/angle gauge, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Dental osteotome :
  • ,
  • Dental torque wrench :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch, reusable :
  • ,
  • Fixture/appliance dental drill bit, reusable :
  • ,
  • Dental implant suprastructure, temporary, preformed, reusable :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Craniofacial bone screw, non-bioabsorbable, sterile :
  • ,
  • Screw endosteal dental implant, two-piece :
  • ,
  • Dental implant abutment analog, scanning :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Surgical instrument handle, non-torque-limiting :
  • ,
  • Orthopaedic implant/instrument depth limiter :
Biotech Europe Meditech Inc LimitedAF2 IDA Business and Technology Park

Roscommon
F42 P862

Ireland

NEUVIDA MEDICAL DEVICE INC LIMITEDUK Responsible Person25 Leeming Road

Borehamwood
Hertfordshire WD6 4EB

England United Kingdom

04/30/202114254
  • Posterior-chamber intraocular lens, pseudophakic :
  • ,
  • Manual intraocular lens injector, single-use :
  • ,
  • Synovial fluid supplementation medium :
  • ,
  • Dermal tissue reconstructive material, microbe-derived :
  • ,
  • Vitreous/aqueous humour replacement medium, intraoperative :
  • ,
  • Vitreous humour replacement medium, postoperative :
  • ,
  • Ophthalmic surgical dye :
Biotech GmbHHagenauer Str. 17-19

Wiesbaden
65203

Germany

Calmedical LtdUK Responsible PersonLangton Kennels DUNS
TD11 3QN
Langton Kennels
TD11 3QN

Scotland United Kingdom

04/15/202113441
  • Funnel chest remodelling bar :
Biotech Inc5975 Shiloh Road Suite 101

Alpharetta
Georgia GA 30005

United States

NB Insight LtdUK Responsible Person39 Lambourn Avenue Stone Cross
Pevensey
Pevensey
East Sussex BN24 5PQ

England United Kingdom

08/16/202116811
  • Assisted reproduction vitrification carrier :
Biotechni SASZ.I. Athelia II 178 avenue du serpolet

La Ciotat
Cedex F 13704

France

United Orthopedic Corporation (UK) LimitedUK Responsible PersonBaileys Barn Pimlico Farm
Austrey Lane
No Mans Heath
Warwickshire B79 0PF

England United Kingdom

04/26/202113890
  • Revision coated femoral stem prosthesis :
BioTeke Corporation (Wuxi) Co. Ltd4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi

Jiangsu Province
214174

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom

04/21/202112460
  • Oral/upper respiratory tract specimen collection swab :
  • ,
  • SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • General specimen collection kit IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) :
  • ,
  • Nucleic acid sample preparation instrument IVD, automated :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • SARS-CoV-2 neutralizing antibody IVD, kit, immunochromatographic test (ICT), rapid :
Bioteque Corporation5F-6 No. 23 Sec.1 Chang-An E Rd

Taipei 104
104

Taiwan

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH

England United Kingdom

06/17/202115218
  • Polymeric ureteral stent :
  • ,
  • Airway suction catheter :
  • ,
  • Cardiac/peripheral vascular guidewire, single-use :
  • ,
  • Haemodialysis needle :
  • ,
  • Double-lumen haemodialysis catheter, nonimplantable :
  • ,
  • Vascular catheter introduction set, nonimplantable :
  • ,
  • Wearable percutaneous catheter/tube holder :
  • ,
  • Closed-wound/centesis drainage receptacle :
  • ,
  • Multi-purpose percutaneous abdominothoracic drainage catheter :
BioTissue SA1 Rue de Chantepoulet

Geneva
CH-1201

Switzerland

QAdvis UK LtdUK Responsible Person55-66 Frederick Street

Edinburgh EH2 1LS
EH2 1LS

Scotland United Kingdom

04/30/202114294
  • Multi-purpose surgical mesh, synthetic polymer, bioabsorbable :
BIOTRONICS 3D LIMITED5 Greenwich View Place

London
E14 9NN

England United Kingdom








08/18/202117323
  • Radiology PACS software :
BIOTRONIK AGAckerstrasse 6

Bulach
8180

Switzerland

BIOTRONIK UK LIMITEDUK Responsible PersonBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA

United Kingdom

03/25/202112897
  • Bare-metal coronary artery stent :
  • ,
  • Drug-eluting coronary artery stent, fully-bioabsorbable :
  • ,
  • Drug-eluting coronary artery stent, bioabsorbable-polymer-coated :
  • ,
  • Cardiac/peripheral vascular guidewire, single-use :
  • ,
  • Peripheral angioplasty balloon catheter, basic :
  • ,
  • Coronary angioplasty balloon catheter, basic :
  • ,
  • Multiple peripheral artery stent, bare-metal :
  • ,
  • Bare-metal renal artery stent :
  • ,
  • Iliac artery stent, bare-metal :
BIOTRONIK SE & Co. KGWoermannkehre 1

Berlin
12161

Germany

BIOTRONIK UK LIMITEDUK Responsible PersonBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA

United Kingdom

03/08/202112556
  • Single-chamber implantable defibrillator :
  • ,
  • Cardiac resynchronization therapy implantable pacemaker :
  • ,
  • Dual-chamber implantable pacemaker, rate-responsive :
  • ,
  • Single-chamber implantable pacemaker, rate-responsive :
  • ,
  • Dual-chamber implantable defibrillator :
  • ,
  • Cardiac resynchronization therapy implantable defibrillator :
  • ,
  • Pacing/defibrillation lead repair kit :
  • ,
  • Pacing/defibrillation lead cap :
  • ,
  • Implantable pulse generator port plug :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Pacing/defibrillation lead suture sleeve :
  • ,
  • Vascular catheter stylet :
  • ,
  • Coronary venous pacing lead :
  • ,
  • Endocardial pacing lead :
  • ,
  • Implantable cardiac monitor programmer/transmitter/alarm :
  • ,
  • Implantable cardiac monitor :
  • ,
  • Cardiac pulse generator reader, home-use :
  • ,
  • Endocardial defibrillation lead :
  • ,
  • Surgical screwdriver, single-use, sterile :
  • ,
  • Vascular guide-catheter, single-use :
  • ,
  • Vascular catheter introduction set, nonimplantable :
  • ,
  • Intravascular catheter slitter :
  • ,
  • Cardiac pulse generator programmer :
  • ,
  • Implantable pacemaker analyser, intraoperative :
  • ,
  • Electrocardiographic lead set, reusable :
  • ,
  • Vein pick :
  • ,
  • Electrical-only medical device connection cable, reusable :
  • ,
  • Implantable cardiac device management application software :
  • ,
  • Cardiac radio-frequency ablation system generator :
  • ,
  • Cardiac electrophysiology stimulation system :
  • ,
  • External pacemaker, transcutaneous pacing :
Biovault Technical Ltd24 Brest Road Derriford

Plymouth
Devon PL6 5XP

United Kingdom








02/19/20145524
  • Umbilical cord blood collection set :
Bioventus LLC4721 Emperor Blvd Suite 100

Durham
North Carolina 27703

United States

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

Cambridge
CB24 9BZ

England United Kingdom

05/03/202114355
  • Synovial fluid supplementation medium :
  • ,
  • Bone growth ultrasonic stimulator :
  • ,
  • Noninvasive device battery charger :
  • ,
  • Personal device holder, single-use :
  • ,
  • Radiographic image marker, manual :
Biover AGMüliweg 2

Hergiswil
6052

Switzerland

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ

England United Kingdom

12/21/202120778
  • :
BioWave Corporation8 Knight St Suite 201 Norwalk CT 06851

Norwalk
CT 06851

United States

P14 Medical LtdUK Responsible Person65 Bath Road

Stroud
Gloucestershire GL5 3LA

England United Kingdom

10/21/202118164
  • Transcutaneous electrical stimulation electrode adhesive pad :
  • ,
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
  • ,
  • Analgesic PENS system probe, single-use :
  • ,
  • Analgesic transcutaneous electrical nerve stimulation system :
  • ,
  • Transcutaneous electrical stimulation electrode, reusable :
Bioxal SARoute des Varennes

Chalon sur Saône
71100

France

Schülke & Mayr UK LtdUK Responsible PersonCygnet House

Sheffield
S9 1AT

England United Kingdom

11/24/202120198
  • Medical device disinfection agent :
Bio/Data Corporation155 Gibraltar Road

Horsham
PA 19044

United States

Alpha Laboratories LtdUK Responsible PersonUnit 40 Parham Drive

Eastleigh
Hampshire SO50 4NU

United Kingdom

12/29/202121534
  • :
BIP Biomedizinische Instrumente und Produkte GmbHAm Brand 1

Türkenfeld
82299

Germany

Becton Dickinson U.K. LimitedUK Responsible Person1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom

09/07/202117359
  • End-cut biopsy gun handpiece/needle :
  • ,
  • Imaging lesion localization marker, implantable :
Biplas Medical LtdUnit 3-4 Llantrisant Business Park Llantrisant

Pontyclun
Mid Glamorgan CF72 8LF

United Kingdom








02/02/20112112
  • Ward Dressing Packs :
  • ,
  • Theatre Dressing Packs :
  • ,
  • Oral Hygiene Packs :
  • ,
  • Ophthalmic Surgical Procedure Packs :
  • ,
  • Orthodontic Procedure Packs :
  • ,
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
Birch Dental Laboratory376 Moston Lane Moston

Manchester
Lancashire M40 9LX

United Kingdom








02/09/20176196
  • Dental Appliances/Prostheses :
Birchgrove Optical5a Merthyr Road Whitchurch

Cardiff
CF14 1DA

United Kingdom








11/05/20091673
  • Prescribed Spectacles :
Birchwood Health Ltd776 Newport Road Rumney

Cardiff
South Glamorgan CF3 4FG

United Kingdom








01/06/20144530
  • Dental Appliances/Prostheses :
Bird & Fairley (Loughton) Ltd269 High Road

Loughton
Essex IG10 1AH

United Kingdom








03/05/20081954
  • Spectacle Lenses :
  • ,
  • Spectacle Frames :
Birkbeck College University of LondonMalet Street

London
WC1E 7HX

United Kingdom








02/23/20165903
  • Self-care monitoring/reporting software :
Birmingham Biotech LTD29-31 Castle Street

High Wycombe
HP13 6RU

England United Kingdom








12/07/202011084
  • SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid :
  • ,
  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) :
Birmingham Community Healthcare NHS Foundation TrustUnit 3 Priestley Wharf 20 Holt Street

Birmingham
West Midlands B7 4BN

United Kingdom








12/01/20166150
  • Self-care monitoring/reporting software :
  • ,
  • Bar dental precision attachment :
  • ,
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental bridge, ceramic :
  • ,
  • Dental bridge, metal-ceramic :
  • ,
  • Dental bridge, metal-polymer :
  • ,
  • Dental bridge, polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • 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 implant suprastructure, temporary, custom-made :
  • ,
  • Dental implant suprastructure, permanent, custom-made :
  • ,
  • Dental implant welding system :
  • ,
  • Dental implantation drilling template, custom-made :
  • ,
  • Dental base plate :
  • ,
  • Dental impression tray, single-use :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Dental veneer, professional :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Denture clasp, metal, custom-made :
  • ,
  • Denture clasp, metal, preformed :
  • ,
  • Denture clasp, polymer, preformed :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Root canal post, custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic anchor plate :
  • ,
  • Orthodontic anchoring screw :
  • ,
  • Orthodontic appliance positioning tray, basic :
  • ,
  • Orthodontic archwire/bracket ligature :
  • ,
  • Orthodontic band material :
  • ,
  • Orthodontic clasp, metal wire, custom-made :
  • ,
  • Orthodontic spring :
  • ,
  • Denture reliner, elastic, long-term :
Birmingham Metal LtdGarrison Street Bordesley

Birmingham
West Midlands B9 4BN

United Kingdom








09/21/991334
  • Orthodontic Materials (Extra-Oral/Intra-Oral Transient And Short-Term Use) :
  • ,
  • Base Materials :
Birmingham Optical583 Moseley Road

Birmingham
West Midlands B12 9BL

United Kingdom








04/28/20144392
  • Sight Testing Devices :
Birmingham Orthotic Services LTDUnit E10 Hastingwood Industrial Park
Wood Lane Erdington
Birmingham
B24 9QR

Wales United Kingdom








01/07/202221862
  • :
BIRR Bio Sciences BVBreedstraat 17 Bergseweg 4

3633 AX Vreeland
3633

Netherlands

Hunter Scientific LtdUK Responsible PersonUnit 1 Priors Hall Widdington

Saffron Walden
Essex CB11 3SB

United Kingdom

11/01/202118631
  • Mechanical pipette :
  • ,
  • Assisted reproduction needle, single-use :
  • ,
  • Assisted reproduction microtool :
  • ,
  • Assisted reproduction procedure dish :
  • ,
  • Assisted reproduction centrifuge tube :
  • ,
  • General laboratory container, single-use, sterile :
Bisco Inc.1100 W. Irving Park Road

Schaumburg
IL 60193

United States

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

Cambridge
CB24 9BZ

England United Kingdom

10/18/202118324
  • Dental unfilled resin sealant/coating :
  • ,
  • Dentine bonding agent/set :
  • ,
  • Dental material application tool, single-use :
  • ,
  • Dental composite resin :
  • ,
  • Dental etching solution :
  • ,
  • Dental material mixing surface, single-use :
  • ,
  • Dental material mixing nozzle, non-sterile :
  • ,
  • Dental material injection cannula, single-use :
  • ,
  • Dental cement trial :
  • ,
  • Dental coating, bond-reduction :
  • ,
  • Dental prosthesis priming agent :
  • ,
  • Dental composite resin kit :
  • ,
  • Dental restoration fixation cleaning solution :
  • ,
  • Dental etching solution syringe :
Bishop's Stortford Orthodontic Practice.30 Stansted Road

Bishop's Stortford
Hertfordshire CM23 2DX

United Kingdom








08/28/20091772
  • Dental Appliances/Prostheses :
Bistos Co. Ltd.7th Fl. A Bldg Woolim Lions Valley 5-cha 302
Galmachi-ro Jungwon-gu
Seongnam-si
Gyeonggi-do 13201

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom

09/21/202117737
  • Overhead infant phototherapy unit :
  • ,
  • Breast pump, electric :
  • ,
  • Foetal cardiac monitor :
  • ,
  • Foetal Doppler system :
  • ,
  • Pulse oximeter :
  • ,
  • Head-worn lamp :
  • ,
  • Breast pump support kit, reusable :
Bite Easy Dental Laboratory61B Wicker

Sheffield
South Yorkshire S3 8HT

England United Kingdom








02/01/202111896
  • Custom-made dental crown, ceramic :
  • ,
  • Custom-made dental crown, metal :
  • ,
  • Dental bridge, metal-ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge, metal-polymer :
  • ,
  • Dental bridge, polymer :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Root canal post, custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Dental occlusal splint, preformed, reusable :
  • ,
  • Dental implant abutment analog, scanning :
  • ,
  • Custom-made dental crown, metal/ceramic :
  • ,
  • Custom-made dental crown, metal/polymer :
  • ,
  • Custom-made dental crown, polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Preformed dental crown, permanent :
  • ,
  • Preformed dental crown, temporary :
  • ,
  • Dental cusp, permanent :
  • ,
  • Dental cusp, temporary :
  • ,
  • Resin dental inlay :
  • ,
  • Denture reliner, hard :
  • ,
  • Denture clasp, metal, custom-made :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental bridge, ceramic :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental prosthesis veneer resin :
Bite Makers20 Hampton Drive Kings Sutton

Banbury
Oxon OX17 3QR

United Kingdom








11/22/20175735
  • Dental Appliances/Prostheses :
Biterite Ltd1019c Portsdown Mews

London
NW11 7ES

United Kingdom








06/09/20095496
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown, ceramic :
  • ,
  • Custom-made dental crown, metal :
  • ,
  • Root canal post, custom-made :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Partial denture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental impression tray, single-use :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Resin dental inlay :
  • ,
  • Custom-made dental crown, metal/ceramic :
  • ,
  • Gold dental inlay :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental implant suprastructure, permanent, custom-made :
  • ,
  • Dental implant suprastructure, temporary, preformed, reusable :
  • ,
  • Custom-made dental crown, metal/polymer :
  • ,
  • Custom-made dental crown, polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental bridge, ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge, metal-polymer :
  • ,
  • Dental bridge, metal-ceramic :
Bitesize dental laboratory83 Brook Street Raunds

Wellingborough
Northamptonshire NN9 6LL

United Kingdom








05/14/20155192
  • Dental Appliances/Prostheses :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Denture cleaning container :
  • ,
  • Denture cleaning brush :
  • ,
  • Denture cleanser :
  • ,
  • Denture reliner, elastic, short-term :
  • ,
  • Denture reliner, hard :
  • ,
  • Denture reliner, soft, home-use :
  • ,
  • Denture reliner, soft, professional :
  • ,
  • Denture repair kit, professional :
  • ,
  • Denture retention spring :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Bite registration rim :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim wax, plate :
  • ,
  • Dental impression tray material :
  • ,
  • Dental impression tray, reusable :
  • ,
  • Dental impression tray, single-use :
  • ,
  • Agar dental impression material :
  • ,
  • Alginate dental impression material :
  • ,
  • Bar dental precision attachment :
  • ,
  • Denture clasp, metal, custom-made :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Dental occlusal splint, customizable :
  • ,
  • Dental occlusal splint, preformed, reusable :
  • ,
  • Custom-made mouthguard :
  • ,
  • Mouthguard, reusable :
  • ,
  • Bite relief pad :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental implant suprastructure, permanent, preformed :
  • ,
  • Denture clasp mould :
  • ,
  • Dental implant suprastructure, temporary, preformed, single-use :
  • ,
  • Magnetic dental precision attachment :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Orthodontic retainer :
  • ,
  • Resin dental inlay :
  • ,
  • Dental implant suprastructure, temporary, preformed, reusable :
  • ,
  • Hand-held dental retractor :
  • ,
  • Preformed dental crown, temporary :
  • ,
  • Preformed dental crown, permanent :
  • ,
  • Denture clasp, metal, preformed :
  • ,
  • Fluoride gel tray :
  • ,
  • Dental bridge, metal-polymer :
  • ,
  • Dental bridge, polymer :
  • ,
  • Dental appliance fabrication material, resin :
  • ,
  • Dental appliance fabrication material, thermoplastic :
  • ,
  • Dental base plate :
  • ,
  • Dental implant abutment analog, laboratory :
  • ,
  • Mouthguard, single-use :
  • ,
  • Orthodontic clasp, metal wire, custom-made :
  • ,
  • Orthodontic clasp, metal, custom-made :
  • ,
  • Denture clasp, polymer, preformed :
  • ,
  • Orthodontic clasp, metal, preformed :
  • ,
  • Orthodontic teeth positioner, preformed :
  • ,
  • Dental implant x-ray template :
  • ,
  • Custom-made organ/bone anatomy model :
  • ,
  • Gypsum dental anatomy model material :
  • ,
  • Polymer-based dental model material :
  • ,
  • Dental mould :
  • ,
  • Dental composite resin :
  • ,
  • Composite dental impression material :
  • ,
  • Surgical implant template, reusable :
  • ,
  • Denture cushion :
  • ,
  • Surgical implant template, single-use :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental prosthesis/implant abutment screw analog, reusable :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental implant system :
  • ,
  • Dental implantation depth/angle gauge, reusable :
  • ,
  • Dental wrought alloy :
  • ,
  • Dental soldering alloy :
  • ,
  • Dental brazing alloy :
  • ,
  • Denture base resin kit :
  • ,
  • Dental casting noble alloy :
  • ,
  • Dental casting non-noble alloy :
  • ,
  • Custom-made dental crown, metal :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown, ceramic :
  • ,
  • Custom-made dental crown, metal/ceramic :
  • ,
  • Custom-made dental crown, metal/polymer :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental appliance fabrication material, ceramic :
  • ,
  • Denture reliner, elastic, long-term :
  • ,
  • Dental appliance fabrication material, combination-material :
  • ,
  • Dental prosthesis fabrication material, polymer :
  • ,
  • Dental prosthesis dye :
  • ,
  • Dental prosthesis restorative material, unfilled resin :
  • ,
  • Multi-purpose surgical mesh, metallic :
Biting Edge Dental Laboratory30 Queens Drive

Huntingdon
PE29 1UW

United Kingdom








09/29/20176239
  • Dental Appliances/Prostheses :
  • ,
  • Bite registration rim wax :
  • ,
  • Dental occlusal splint, preformed, reusable :
  • ,
  • Overdenture :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Denture clasp, metal, preformed :
  • ,
  • Denture clasp, polymer, preformed :
  • ,
  • Mouthguard, reusable :
  • ,
  • Orthodontic retainer :
  • ,
  • Partial denture :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Preformed complete denture :
  • ,
  • Dental appliance fabrication material, thermoplastic :
bitop AGStockumer Straße 28

Witten
58453

Germany

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

Cambridge
CB24 9BZ

England United Kingdom

10/27/202118511
  • Eye lubricant :
  • ,
  • Skin moisture barrier dressing :
  • ,
  • Oropharyngeal mucosa protection material :
  • ,
  • Nasal mucosa dressing, non-antimicrobial :
Bitterne Park Dental Laboratory3 The Triangle Bitterne Park
Southampton
Southampton
Hampshire SO18 1FZ

United Kingdom








05/08/20198705
  • Denture clasp, metal, preformed :
Bitteswell Employment Alliance LtdUnit 1 Arches Industrial Estate Spon End

Coventry
West Midlands CV1 3JQ

United Kingdom








08/03/2001830
  • Patient Hoists/ Transfer Aids And Accessories :
Bittium Biosignals LtdPioneerinkatu 6 Pioneerinkatu 20

Kuopio
70800

Finland

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

Cambridge
CB24 9BZ

England United Kingdom

09/24/202117826
  • Telemetric electrocardiographic ambulatory recorder :
  • ,
  • Cardiac electrophysiology application software :
Bizztrex InternationalRchna Center Razi ENT Commissioner Road Bizztrex International Barlas street Kashmir road

Sialkot
Punjab 51310

Pakistan

BIZZTREX LTDUK Responsible Person37 heyford avenue

Bristol
BS5 6UD

England United Kingdom

04/26/202113797
  • Wire cutter :
  • ,
  • Vaginal speculum, reusable :
  • ,
  • Towel clamp, reusable :
  • ,
  • Dental elevator, tooth/root :
  • ,
  • Suturing needle holder, reusable :
  • ,
  • Surgical screwdriver, reusable :
  • ,
  • Surgical probe/cannula bending tool :
  • ,
  • Surgical gouge :
  • ,
  • Surgical depth gauge, reusable :
  • ,
  • Amputation knife :
  • ,
  • Bone collection scraper :
  • ,
  • Bone file/rasp, reciprocating, reusable :
  • ,
  • Bone curette, reusable :
  • ,
  • Bone cutting forceps :
  • ,
  • Bone holding forceps :
  • ,
  • Bone hook :
  • ,
  • Bone lever/elevator :
  • ,
  • Cannulated surgical drill bit, reusable :
  • ,
  • Cast cutting scissors :
  • ,
  • Cast cutting shears :
  • ,
  • Chisel/osteotome blade handle :
  • ,
  • Paraffin wax knife :
  • ,
  • Percussion hammer, manual :
  • ,
  • Periodontal curette :
  • ,
  • Periosteal elevator, reusable :
  • ,
  • Rib spreader, reusable :
  • ,
  • Rubber dam clamp :
  • ,
  • Rubber dam kit :
  • ,
  • Scalpel handle, reusable :
  • ,
  • Self-retaining surgical retractor, reusable :
  • ,
  • Soft-tissue surgical hook, reusable :
  • ,
  • Suction/irrigation tubing, reusable :
  • ,
  • Surgical bulldog clamp, reusable :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Surgical mallet head :
  • ,
  • Surgical soft-tissue manipulation forceps, alligator, reusable :
  • ,
  • Surgical countersink, reusable :
  • ,
  • Nasal speculum, reusable :
  • ,
  • Obstetrical forceps, reusable :
  • ,
  • Orthodontic pliers :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Mouth gag, adjustable, reusable :
  • ,
  • Mechanical stethoscope :
  • ,
  • Manual dental scaler, reusable :
  • ,
  • Manual surgical saw blade, rigid :
  • ,
  • Manual bone mill :
  • ,
  • Laryngoscope blade, reusable :
  • ,
  • Instrument tray, reusable :
  • ,
  • Hand-held surgical retractor, reusable :
  • ,
  • General-purpose surgical scissors, reusable :
  • ,
  • Fixture/appliance dental drill bit, reusable :
  • ,
  • Fixed-diameter cervical dilator, reusable :
  • ,
  • ENT diagnostic set :
  • ,
  • Ear speculum, reusable :
  • ,
  • Laryngoscope handle, reusable :
  • ,
  • Dental amalgam carrier :
  • ,
  • Dental amalgam well :
  • ,
  • Dental articulator :
  • ,
  • Dental cheek retractor, professional, reusable :
  • ,
  • Dental dressing forceps, reusable :
  • ,
  • Dental osteotome set :
  • ,
  • Dental restoration carver, amalgam, reusable :
  • ,
  • Dental soft-tissue coring punch, reusable :
  • ,
  • Dental torque wrench adaptor :
  • ,
  • Dental anaesthesia syringe, reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Dental impression tray, reusable :
  • ,
  • Dental mirror, reusable :
  • ,
  • Dissection kit :
  • ,
  • Dressing/utility forceps, scissors-like, reusable :
  • ,
  • Dressing/utility forceps, tweezers-like, reusable :
  • ,
  • Vascular scissors :
  • ,
  • Dental explorer :
  • ,
  • Orthopaedic implantation sleeve, reusable :
  • ,
  • Periodontal probe, reusable :
Black and Black Surgical5175 South Royal Atlanta Drive

Tucker
Georgia 30084

United States

Eurosurgical LtdUK Responsible PersonMerrow Business Park
Guildford
Guildford
Surrey GU4 7WA

England United Kingdom

11/12/202119107
  • Suction/irrigation tubing, single-use :
Black Swan Dental Spa21a-23a Market Street

Crewkerne
Somerset TA18 7JU

United Kingdom








05/10/20198126
  • Orthodontic retainer :
Black Tie Medical Inc. DBA Tulip Medical Products4360 Morena Blvd. Suite 100

San Diego
California 92117

United States

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

Cambridge
CB24 9BZ

England United Kingdom

12/10/202120433
  • :
Black & Lizars Ltd17 Robert Drive

Glasgow
Lanarkshire G51 3HE

United Kingdom








05/29/20091475
  • Spectacle Frames :
  • ,
  • Prescribed Spectacles :
Blackburn VE Limited236 Cobden Court

Blackburn
BB1 7JG

United Kingdom








03/06/20075490
  • Prescribed Spectacles :
Blackmoor Developments LtdBlackmoor Farm Doddington

Lincoln
Lincolnshire LN6 4RR

United Kingdom








11/05/991361
  • Rehabilitation Equipment :
Blackpool Teaching Hospital NHS Foundation TrustWhinney Heys Road

Blackpool
Lancashire FY3 8NR

United Kingdom








03/18/20117230
  • ENT surgical 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 :
  • ,
  • Laparoscopic surgical procedure kit, non-medicated, reusable :
  • ,
  • Arthroscopic surgical procedure kit, non-medicated, reusable :
  • ,
  • Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable :
  • ,
  • General surgical procedure kit, non-medicated, reusable :
  • ,
  • Cardiothoracic surgical procedure kit, non-medicated, reusable :
Blanco Dental Solutions Laboratory Ltd.2 Ridgeway
GBR
FERNDOWN
Dorset BH22 8TU

United Kingdom








08/14/20198971
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint, custom-made :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Ceramic dental inlay :
Blandford Dental Laboratories451 Ringwood Road Parkstone

Poole
Dorset BH12 4LX

United Kingdom








08/25/99567
  • Dental Appliances/Prostheses :
Blandford DentalSuite S1 Waterside Centre North Street

Lewes
East Sussex BN7 2PE

United Kingdom








08/25/99340
  • Dental Appliances/Prostheses :
Blasta Henriet LtdApartment 23 Chancery Building 3 New Mill Road

London
SW11 7AS

United Kingdom








06/07/20176206
  • Hot/cold therapy pack, reusable :
Blatchford Products LimitedLister Road

Basingstoke
Hampshire RG22 4AH

United Kingdom








08/25/99187
  • Orthoses (Lower And Upper Limb/Spinal/Abdominal/Neck/Head) :
  • ,
  • External Limb Prostheses And Accessories :
  • ,
  • Orthoses And Prostheses - External (Made Direct From Casts/Prescriptions) :
  • ,
  • External limb prosthesis socket liner :
  • ,
  • External lower-limb prosthesis axial rotator/load attenuator :
  • ,
  • Mechatronic external knee prosthesis :
  • ,
  • Hydraulic/pneumatic external knee prosthesis :
  • ,
  • Mechatronic external ankle-foot prosthesis :
  • ,
  • External limb prosthesis finishing component, non-customized :
  • ,
  • External limb prosthesis socket shell fabrication material :
  • ,
  • External lower-limb prosthesis socket, non-customized :
  • ,
  • External lower-limb prosthesis structural/alignment component :
  • ,
  • Mechanical-resistance external ankle-foot prosthesis :
  • ,
  • Mechanical-resistance external knee prosthesis :
  • ,
  • Multiple-joint external lower-limb prosthesis system :
  • ,
  • Hydraulic/pneumatic external ankle-foot prosthesis :
Bliinx EyecareGanders House Ganders Park Forge Road Kingsley

Bordon
Hampshire GU35 9LU

United Kingdom








08/29/20145557
  • Prescribed Spectacles :
Blink Device Company1530
Westlake Ave N #600 Seattle
King
WA 98109

United States

Fannin (UK) LtdUK Responsible PersonUnit 100 Westminster Industrial Estate
Repton Road Measham
Swadlincote
Derbyshire DE12 7DT

United Kingdom

08/11/202116645
  • Nerve-function monitor :
  • ,
  • Patient monitoring system module, nerve location :
Blink Eye Wear Ltd18 High Street

Redcar
Cleveland TS10 3DU

United Kingdom








05/06/20113655
  • Spectacle Frames :
  • ,
  • Ready-Made Spectacles (Non-Prescribed) :
  • ,
  • Prescribed Spectacles :
  • ,
  • Spectacle Lenses :
Blink Medical LtdUnit 40 Radway Road Shirley

Solihull
B90 4NS

United Kingdom








09/20/20105479
  • Eyelid speculum, single-use :
  • ,
  • Scalpel handle, single-use :
  • ,
  • Ear speculum, single-use :
  • ,
  • Dressing/utility forceps, scissors-like, single-use :
  • ,
  • Dental explorer :
  • ,
  • Tongue depressor, examination, single-use :
  • ,
  • Nasal speculum, single-use :
  • ,
  • Vaginal speculum, single-use :
  • ,
  • Dressing/utility forceps, tweezers-like, single-use :
  • ,
  • Dental anaesthesia syringe, single-use :
  • ,
  • Medication cartridge syringe, needleless, single-use :
  • ,
  • Dental mirror, single-use :
  • ,
  • Endaural surgical curette, single-use :
  • ,
  • Scleral marker, single-use :
  • ,
  • General/plastic surgical procedure kit, non-medicated, single-use :
  • ,
  • Ophthalmic surgical procedure kit, non-medicated, single-use :
  • ,
  • Open-surgery electrosurgical handpiece/electrode, bipolar, single-use :
  • ,
  • Surgical soft-tissue manipulation forceps, scissors-like, single-use :
  • ,
  • Eyelid clamp :
  • ,
  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use :
  • ,
  • Surgical bulldog clamp, single-use :
  • ,
  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use :
  • ,
  • Ophthalmic surgical device handling forceps :
  • ,
  • Surgical soft-tissue manipulation forceps, alligator, single-use :
  • ,
  • Suturing needle holder, single-use :
  • ,
  • General-purpose curette :
  • ,
  • Corneal trephine, single-use :
  • ,
  • Conjunctival trocar blade :
  • ,
  • Surgical irrigation/aspiration cannula, non-illuminating, single-use :
  • ,
  • Liposuction system cannula, single-use :
  • ,
  • Surgical/emergency suction cannula, non-illuminating, single-use :
  • ,
  • Open-surgery biopsy forceps, single-use :
  • ,
  • Enucleation scissors :
  • ,
  • Suture scissors :
  • ,
  • General-purpose surgical scissors, single-use :
  • ,
  • Intraocular scissors, conventional-hinge, single-use :
  • ,
  • Ophthalmic strabismus scissors :
  • ,
  • Conjunctival scissors :
  • ,
  • Ear scissors, single-use :
  • ,
  • Lacrimal dilator, single-use :
  • ,
  • Lacrimal probe, single-use :
  • ,
  • Self-retaining surgical retractor, single-use :
  • ,
  • Ocular hook/spatula/manipulator, single-use :
  • ,
  • Hand-held surgical retractor, single-use :
  • ,
  • Ophthalmic surgery fluid retention ring :
  • ,
  • ENT probe, single-use :
  • ,
  • Soft-tissue surgical hook, single-use :
  • ,
  • Eyeball fixation instrument, single-use :
Blink Optics Limited327 Upper Richmond road West East Sheen

London
SW14 8QR

United Kingdom








10/10/20177180
  • Prescription spectacle lens, custom-made :