Manufacturer's By Name

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Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
121 Dental Laboratory121 Earls Court

London
SW5 9RL

United Kingdom





03/23/20176091
  • Dental Appliances/Prostheses :
151 Products Limited39 Bengal Street
The Old School House 39 Bengal Street Manchester
MANCHESTER
Greater Manchester M4 6AF

England United Kingdom

fday@151.co.uk





04/30/20157197
  • Circulating-air whole-body heating/cooling system pad single-use non-sterile :
    • ,
  • First aid kit non-medicated reusable :
    • ,
  • First aid kit non-medicated single-use :
    • ,
  • Non-woven gauze pad non-sterile :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD reagent :
    • ,
  • Cold/cool therapy spray :
    • ,
  • Adhesive bandage :
    • ,
  • Pressure bandage Hevea-latex single-use :
    • ,
  • Tubular support bandage Hevea-latex :
    • ,
  • Cold/cool therapy gel :
    • ,
  • Corn/callus dressing single-use :
    • ,
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
    • ,
  • Nasal breathing aid external :
    • ,
  • Nose clip reusable :
    • ,
  • Acupressure wristband :
    • ,
  • Butterfly skin-closure adhesive strip :
    • ,
  • Dressing-fixation skin adhesive tape non-silicone :
    • ,
  • Bunion shield :
    • ,
  • Tubular support bandage Hevea-latex :
    • ,
  • Acupressure wristband :
    • ,
  • Nose clip reusable :
    • ,
  • Cold/cool therapy gel :
    • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
    • ,
  • Butterfly skin-closure adhesive strip :
    • ,
  • Skin-cover adhesive strip antimicrobial :
    • ,
  • Pressure bandage Hevea-latex single-use :
    • ,
  • Nasal breathing aid external :
    • ,
  • Cold/cool therapy spray :
    • ,
  • Bunion shield :
    • ,
  • Corn/callus dressing single-use :
    • ,
  • First aid kit non-medicated single-use :
    • ,
  • Human Chorionic Gonadotropin Total :
    • ,
  • Chiropody Dressings And Pads :
    • ,
  • Acupressure Devices and Copper Bracelets :
    • ,
  • Exothermic heat therapy pack/patch :
1987 Media LimitedMartinique House C/O Top Branch Partners Hampshire Road

Bordon
Hampshire GU350HJ

England United Kingdom





09/28/202118945
  • Mouthguard reusable :
1STCHOICE DENTAL LABORATORY LTD196 Cotmanhay Road

Ilkeston
Derbyshire DE7 8RB

United Kingdom





08/08/20176305
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Orthodontic clasp metal preformed :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure temporary custom-made :
    • ,
  • Dental implantation drilling template custom-made :
    • ,
  • Denture reliner hard :
    • ,
  • Denture reliner soft professional :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Dental cusp permanent :
    • ,
  • Dental cusp temporary :
    • ,
  • Root canal post custom-made :
    • ,
  • Gold dental inlay :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental veneer professional :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Custom-made mouthguard :
    • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
    • ,
  • Resin dental inlay :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental implant abutment analog scanning :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge ceramic :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Ceramic dental inlay :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Overdenture :
    • ,
  • Orthodontic retainer :
    • ,
  • Complete lower denture :
    • ,
  • Partial denture :
    • ,
  • Complete upper denture :
    • ,
  • Complete lower denture :
1stQ GmbHHarrlachweg1

Mannheim
68163

Germany

Vision Matrix LtdUK Responsible PersonVision Matrix Ltd 31 East Parade

Harrogate
North Yorkshire HG1 5LQ
UK Responsible Person
England United Kingdom
04/19/202213735
  • Posterior-chamber intraocular lens pseudophakic :
21 Century Medical Co.32 Jungga-ro

Gwangju
Buk-gu 500-510

South Korea

OXXOT LtdUK Responsible Person11Eastwood Court Wiltshire Rd

Marlow
Bucks SL7 1JG
UK Responsible Person
England United Kingdom
01/29/202111848
  • Polydioxanone/polyethylene suture :
21MC Grup ç ve D Tic. Ltd. ti.Acarlar Mah. 9 Cad. No:1 Kat:5 ç Kap No: 30 Coliseum Binas

Istanbul
34800

Turkey

Zaza London LimitedUK Responsible Person2 Meyrick Road

London
Dollis Hill NW10 2EJ
UK Responsible Person
England United Kingdom
06/13/202224840
  • Isolation gown single-use :
    • ,
  • Scrub suit single-use :
    • ,
  • Shoe cover :
    • ,
  • Surgical cap single-use :
23andMe Inc.349 Oyster Point Blvd

South San Francisco
California 94080

United States

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
04/13/202224248
  • Human genomic analysis interpretive software IVD :
270 Vision Limitedc/o Trethowans LLP The Pavilion
Botleigh Grange Business Park Hedge End
Southampton
Hampshire S030 2AF

United Kingdom





04/20/20165958
  • Electronic goniometer/kinesiology sensor :
    • ,
  • Electronic goniometer/kinesiology sensor :
2nd Nature Dental Laboratory Ltd5 Kings Road

Newtownabbey
Antrim and Newtownabbey BT37 0DA

Northern Ireland United Kingdom

info@2ndnaturedental.co.uk





10/01/20105133
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Teeth whitening tray :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Vacuum mouldable splint :
    • ,
  • Mouthguard single-use :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implant suprastructure permanent preformed :
    • ,
  • Dental implant suprastructure temporary preformed reusable :
    • ,
  • Dental implant suprastructure temporary preformed single-use :
    • ,
  • Dental veneer professional :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Custom-made mouthguard :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Dental base plate :
    • ,
  • Root canal post custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Custom-made dental crown ceramic :
3 DENTAL MANUFACTURING LTD23C Waldon House Mandale Business Park Belmont Industrial Estate
County Durham
County Durham
DH1 1TH

England United Kingdom





02/18/202223135
  • Orthodontic progressive aligner :
313 Visioncare Ltd34-36 High Street

Fordingbridge
Hampshire SP6 1AX

England United Kingdom





01/19/202222158
  • Prescription spectacles :
360 Dent LimitedIDC Valley Drive

Ilkley
LS29 8PB

England United Kingdom





07/15/202116118
  • Digital imaging cassette/storage phosphor screen dental :
    • ,
  • Medical equipment drape single-use :
365 Health Solutions ltdc/o Langtons 100 Old Hall Street

Liverpool
L3 9QJ

England United Kingdom





05/03/202224490
  • Mindfulness/behavioural therapy software non-clinician-consultative :
3A HEALTH CARE S.r.l.Via Marziale Cerutti 90F/G

Lonato del Garda (BS)
25017

Italy

OMRON Healthcare UK Ltd.UK Responsible PersonOpal Drive Fox Milne

Milton Keynes
MK15 0DG
UK Responsible Person
England United Kingdom
06/29/202115583
  • Benchtop nebulizer non-heated :
    • ,
  • Nasal irrigation applicator :
    • ,
  • Nasal aspirator manual :
    • ,
  • Nebulizing system delivery set reusable :
    • ,
  • Suction system canister liner :
    • ,
  • General-purpose surgical suction system electric :
    • ,
  • Emergency airway clearance suction system electric :
3A Medical Products Co. LtdYu An Industrial Park Liu An
Yu An District
Anhui
237100

China

SPIRIT MEDICAL LTDUK Responsible PersonBROOK HOUSE 3A DUFFIELD ROAD
LITTLE EATON
NR DERBY
DERBYSHIRE DE215DR
UK Responsible Person
England United Kingdom
07/27/202116179
  • Surgical gown single-use :
3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)7-C Industrial Area Govindpura
Bhopal
Bhopal
462023

India

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
05/16/202224647
  • Leukaemia-associated fusion gene IVD kit nucleic acid technique (NAT) :
    • ,
  • Nucleic acid extraction/isolation kit IVD :
    • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Colorectal cancer genotyping IVD kit nucleic acid technique (NAT) :
    • ,
  • Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD kit nucleic acid technique (NAT) :
    • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Adenovirus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Microbiological transport medium IVD :
    • ,
  • Thiopurine S-methyltransferase (TPMT) gene polymorphism IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple immunocompromised host infection-associated virus nucleic acid IVD nucleic acid technique (NAT) :
    • ,
  • Leukaemia-associated fusion gene IVD control :
3B BlackBio Biotech India Limited7-C Industrial Area Govindpura

Bhopal Madhya Pradesh
462023

India
+91 755 4076518
info@3bblackbio.com		Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
12/06/202120343
  • Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Philadelphia chromosome/BCR-ABL transcript IVD control :
    • ,
  • Multiple-type tropical pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple Chlamydia species nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Acute myeloid leukaemia (AML) genetic mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • JAK2 V617F gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Methylated DNA IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple Aspergillus species nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • PIK3CA gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Acute promyelocytic leukaemia (APL) genetic mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple Salmonella species nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Orientia tsutsugamushi nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Ankylosing spondylitis IVD kit nucleic acid technique (NAT) :
    • ,
  • Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multidrug-resistant nontuberculous Mycobacterium (NTM) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Chikungunya virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
    • ,
  • KRAS gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • NRAS gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • BRAF V600 gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Dengue virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Myeloproliferative neoplasm-associated multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
    • ,
  • Plasmodium malariae nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Inherited thrombophilia IVD kit nucleic acid technique (NAT) :
    • ,
  • Coagulation factor II (prothrombin) mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT) :
    • ,
  • BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Ebola virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Zika virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Parvovirus B19 nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Toxoplasma gondii nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple Leptospira species nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • KIT gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Calreticulin (CALR) gene mutation IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • MRSA nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple urinary tract infection-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple antimicrobial resistance nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Nucleic acid extraction/isolation kit IVD :
    • ,
  • Colorectal cancer genotyping IVD kit nucleic acid technique (NAT) :
    • ,
  • Leukaemia-associated fusion gene IVD control :
    • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD kit nucleic acid technique (NAT) :
    • ,
  • Thiopurine S-methyltransferase (TPMT) gene polymorphism IVD kit nucleic acid technique (NAT) :
    • ,
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple immunocompromised host infection-associated virus nucleic acid IVD nucleic acid technique (NAT) :
    • ,
  • Adenovirus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Microbiological transport medium IVD :
    • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
    • ,
  • Leukaemia-associated fusion gene IVD kit nucleic acid technique (NAT) :
    • ,
  • Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT) :
3D Biomedicine Science & Technology Co. LtdBlock A Building 2 No. 158 Xinjunhuan Rd

Shanghai
201114

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
12/21/202120776
  • Pipetting system IVD :
    • ,
  • Nucleic acid sample preparation instrument IVD automated :
    • ,
  • Nucleic acid extraction/isolation kit IVD :
    • ,
  • BRCA1/BRCA2 genotyping IVD kit nucleic acid sequencing technique :
    • ,
  • Human genomic analysis interpretive software IVD :
    • ,
  • Cancer-related multiple gene mutation profile kit IVD :
3D Imaging & Simulation Corp Americas365 Herndon Parkway Suite 18

Herndon
Virginia 20170

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
04/05/202223995
  • Intraoral optical scanning system :
3D LifePrints UK LtdThe Innovation Hub Alder Hey Children's Hospital Eaton Road
West Derby
Liverpool
Merseyside L12 2AP

England United Kingdom





05/24/202114923
  • Custom-made organ/bone anatomy model :
    • ,
  • Custom-made orthopaedic/craniofacial surgical guide :
    • ,
  • Custom-made organ/bone anatomy model :
3D MATRIX EUROPE SAS11 CHEMIN DES PETITES BROSSES

CALUIRE ET CUIRE
69300

France

3-D Matrix UK LimitedUK Responsible Person16 Great Queen Street

London
WC2B 5AH
UK Responsible Person
England United Kingdom
04/27/202113971
  • Synthetic peptide haemostatic agent :
    • ,
  • Synthetic peptide haemostatic agent :
3D Metal Printing Ltd.Innovation Centre Broad Quay

Bath
BA1 1UD

United Kingdom





01/18/20198417
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
    • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
    • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
3D Systems Inc.5381 South Alkire Circle

Littleton Colorado
80127

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
03/07/202223430
  • Custom-made organ/bone anatomy model/surgical guide kit :
3DHISTECH KftH-1141

Öv utca. 3.
Budapest Öv utca. 3.

Hungary

Sysmex UK LtdUK Responsible PersonSysmex House Garamonde Drive
Wymbush
Milton Keynes
Buckinghamshire MK8 8DF
UK Responsible Person
England United Kingdom
11/08/202119925
  • Histology/cytology/microbiology image-analysis interpretive software IVD :
3DIEMMERisorgimento 9

Cantu
Como 22063

Italy

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
08/06/202116542
  • CAD/CAM software :
    • ,
  • Dental implantation drilling template guide-sleeve :
    • ,
  • Dental guided surgery reference pin :
3M Company 3M Health Care3M Center 2510 Conway Ave

Saint Paul
Minnesota 55144

United States

3M United Kingdom PLCUK Responsible PersonCain Road

Bracknell
Berkshire RG12 8HT
UK Responsible Person
United Kingdom
03/28/202112914
  • Electronic stethoscope :
    • ,
  • Adhesive bandage :
    • ,
  • Skin stapler/staple non-bioabsorbable :
    • ,
  • Conduction blood/fluid warmer :
    • ,
  • Surgical irrigation tubing set single-use :
    • ,
  • Luer-formatted disinfection cap :
    • ,
  • Synthetic polymer semi-permeable film dressing adhesive :
    • ,
  • Surgical wound protection ring :
    • ,
  • Conduction blood/fluid warmer set :
    • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
    • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
    • ,
  • Conduction blood/fluid warmer :
    • ,
  • Adhesive bandage :
    • ,
  • Cavity-wound management dressing non-antimicrobial :
    • ,
  • Cavity-wound management dressing non-antimicrobial :
    • ,
  • Circulating-air whole-body heating/cooling system control unit :
    • ,
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
    • ,
  • Ethylene oxide device sterilant :
    • ,
  • Wound-nonadherent dressing permeable non-antimicrobial :
    • ,
  • Electrosurgical return electrode single-use :
    • ,
  • Surgical irrigation tubing set single-use :
    • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
    • ,
  • Intravenous pressure infusor manual reusable :
    • ,
  • Continuous electronic patient thermometer line-powered :
    • ,
  • General-purpose patient temperature probe single-use :
    • ,
  • Skin-cover adhesive strip non-antimicrobial :
    • ,
  • Antimicrobial synthetic polymer semi-permeable film dressing adhesive :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
    • ,
  • Ethylene oxide sterilizer :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Pressure bandage non-latex single-use :
    • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
    • ,
  • Skin-closure adhesive strip :
    • ,
  • Adhesive bandage :
    • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
    • ,
  • Skin staple remover single-use :
    • ,
  • Heart valve prosthesis sizer handle :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Pressure bandage Hevea-latex single-use :
    • ,
  • Electrode conductive medium :
    • ,
  • Multifunction body cushion :
    • ,
  • Heart valve sizer reusable :
    • ,
  • Synthetic polymer semi-permeable film dressing adhesive non-sterile :
    • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
    • ,
  • Medical equipment drape single-use :
    • ,
  • Suspension arm sling :
    • ,
  • Mechanical stethoscope :
    • ,
  • Mechanical stethoscope :
    • ,
  • Clavicle orthosis :
    • ,
  • Skin moisture barrier dressing :
    • ,
  • Dressing-fixation skin adhesive tape non-silicone :
    • ,
  • Skin-closure adhesive strip :
    • ,
  • Fresnel lens :
    • ,
  • Waterproof skin adhesive tape :
    • ,
  • Fresnel lens :
    • ,
  • Lumbar spine orthosis :
    • ,
  • Hypoallergenic skin adhesive tape :
    • ,
  • Adhesive bandage :
    • ,
  • Electrocardiographic electrode single-use :
    • ,
  • Surgical hair clippers :
    • ,
  • Surgical/medical face mask single-use :
    • ,
  • Ankle/foot orthosis :
    • ,
  • Knee orthosis :
    • ,
  • Elbow/wrist/hand orthosis :
    • ,
  • Skin-cover adhesive strip non-antimicrobial :
    • ,
  • Circulating-air whole-body heating/cooling system pad single-use non-sterile :
    • ,
  • Pressure bandage Hevea-latex single-use :
    • ,
  • Hypoallergenic skin adhesive tape :
    • ,
  • Antimicrobial synthetic polymer semi-permeable film dressing adhesive :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Mechanical stethoscope :
    • ,
  • Skin-closure adhesive strip :
    • ,
  • Pressure bandage non-latex single-use :
    • ,
  • Nasogastric tube holder noninvasive :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Antimicrobial synthetic polymer semi-permeable film dressing adhesive :
3M Deutschland GmbH Health Care BusinessCari-Schurz-Str. 1

NEUSS
41453

Germany

3M United Kingdom PLCUK Responsible PersonCain Road

Bracknell
Berkshire RG12 8HT
UK Responsible Person
United Kingdom
07/14/202115967
  • Exudate-absorbent dressing non-gel non-antimicrobial :
    • ,
  • Plant polysaccharide haemostatic agent non-bioabsorbable non-antimicrobial :
    • ,
  • Synthetic polymer semi-permeable film dressing adhesive :
    • ,
  • Hot/cold therapy pack single-use :
    • ,
  • Exothermic heat therapy pack/patch :
    • ,
  • Dental cavity varnish :
    • ,
  • Steel dental bur reusable :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Dental unfilled resin sealant/coating :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Dental casting wax :
    • ,
  • Dental composite resin :
    • ,
  • Root canal post preformed :
    • ,
  • Dental abrasive powder :
    • ,
  • Dental root surface conditioner :
    • ,
  • Fatty acid dental cement :
    • ,
  • Fatty acid dental cement :
    • ,
  • Dental material mixing nozzle non-sterile :
    • ,
  • Dental material mixing nozzle non-sterile :
    • ,
  • Dental material injection cannula single-use :
    • ,
  • Dental material injection cannula single-use :
    • ,
  • Dental material cartridge-plunging applicator two-component manual :
    • ,
  • Dental composite resin kit :
    • ,
  • Dental composite resin kit :
    • ,
  • Gingival retraction kit :
    • ,
  • Dental abrasive air jet system handpiece :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Zinc polycarboxylate dental cement :
    • ,
  • Denture reliner hard :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Dental appliance fabrication material ceramic :
    • ,
  • Resin dental inlay :
    • ,
  • Dental impression tray single-use :
    • ,
  • Dental impression material adhesive :
    • ,
  • Sterilization packaging single-use :
    • ,
  • Eye patch :
    • ,
  • Skin-cover adhesive strip non-antimicrobial :
    • ,
  • Cast construction material :
    • ,
  • Cast construction material :
    • ,
  • Compression bandaging kit :
    • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
    • ,
  • Synthetic polymer semi-permeable film dressing adhesive non-sterile :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Medical equipment drape single-use :
    • ,
  • Hot/cold therapy pack reusable :
    • ,
  • Stockinette :
    • ,
  • Surgical/medical face mask single-use :
    • ,
  • Surgical gown single-use :
    • ,
  • Tubular support bandage non-latex reusable :
    • ,
  • Hypoallergenic skin adhesive tape :
    • ,
  • Hypoallergenic skin adhesive tape :
    • ,
  • Surgical hair clippers :
    • ,
  • Dental amalgam mixer :
    • ,
  • Dental material mixing nozzle non-sterile :
    • ,
  • Dental anaesthesia syringe reusable :
    • ,
  • Skin-cover adhesive strip non-antimicrobial :
    • ,
  • Dental material injection cannula single-use :
    • ,
  • Gingival retraction kit :
    • ,
  • Dental impression material adhesive :
    • ,
  • Polyether dental impression material :
    • ,
  • Polyether dental impression material :
    • ,
  • Dental material mixing nozzle non-sterile :
    • ,
  • Dental composite resin :
    • ,
  • Silicone dental impression material :
    • ,
  • Silicone dental impression material :
    • ,
  • Polyether dental impression material :
    • ,
  • Alginate dental impression material :
    • ,
  • Alginate dental impression material :
    • ,
  • Dental composite resin :
    • ,
  • Dental/surgical polymerization lamp :
    • ,
  • Dental material cartridge-plunging applicator two-component manual :
    • ,
  • Dental material cartridge-plunging applicator two-component manual :
    • ,
  • Dental impression material mixer :
    • ,
  • Dental material application tool single-use :
3M ESPE Dental Products2510 Conway Avenue

St. Paul
Minnesota 55144-1000

United States

3M United Kingdom PLCUK Responsible PersonCain Road

Bracknell
Berkshire RG12 8HT
UK Responsible Person
United Kingdom
07/15/202115969
  • Dental cavity varnish :
    • ,
  • Dental unfilled resin sealant/coating :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Resin dental inlay :
    • ,
  • Dental etching solution :
    • ,
  • Dental composite resin :
    • ,
  • Dental composite resin :
    • ,
  • Glass ionomer dental cement :
    • ,
  • Dental collar/crown scissors :
    • ,
  • Orthodontic pliers :
    • ,
  • Dental unfilled resin sealant/coating :
    • ,
  • Dental material application tool single-use :
    • ,
  • Dental abrasive strip single-use :
    • ,
  • Dental composite resin :
    • ,
  • Dental material mixing nozzle non-sterile :
    • ,
  • Dental abrasive disk reusable :
    • ,
  • Dental abrasive disk single-use :
3M United Kingdom PLCCain Road

Bracknell
Berkshire RG12 8HT

United Kingdom





09/16/20102476
  • Surgical/medical respirator non-antimicrobial single-use :
    • ,
  • Surgical/medical respirator non-antimicrobial single-use :
3M Unitek Orthodontic ProductsSouth Peck Road

Monrovia
California 91016

United States

3M United Kingdom PLCUK Responsible PersonCain Road

Bracknell
Berkshire RG12 8HT
UK Responsible Person
United Kingdom
07/15/202115970
  • Glass ionomer dental cement :
    • ,
  • Orthodontic bracket adhesive :
    • ,
  • Orthodontic bracket adhesive :
    • ,
  • Orthodontic archwire/bracket ligature :
    • ,
  • Orthodontic archwire/bracket ligature :
    • ,
  • Orthodontic inter-bracket elastic chain :
    • ,
  • Orthodontic inter-arch elastic band :
    • ,
  • Orthodontic wire :
    • ,
  • Orthodontic retainer :
    • ,
  • Orthodontic bracket metal :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Orthodontic extraoral headgear :
    • ,
  • Orthodontic tube :
    • ,
  • Orthodontic spring :
    • ,
  • Dentine bonding agent/set :
    • ,
  • Orthodontic clasp metal preformed :
    • ,
  • Dental etching solution :
    • ,
  • Dental etching solution :
    • ,
  • Orthodontic metal band :
    • ,
  • Orthodontic lock :
    • ,
  • Orthodontic appliance relief material :
    • ,
  • Orthodontic bracket ceramic :
    • ,
  • Orthodontic bracket adhesive :
    • ,
  • Orthodontic metal band pusher :
    • ,
  • Dental dressing forceps reusable :
    • ,
  • Orthodontic pliers :
    • ,
  • Dental material application tool single-use :
    • ,
  • Dental/surgical polymerization lamp :
    • ,
  • Orthodontic ligature director :
    • ,
  • Orthodontic appliance relief material :
    • ,
  • Dental material injection cannula single-use :
    • ,
  • Dental material cartridge-plunging applicator two-component manual :
    • ,
  • Orthodontic archwire :
3Shape A/SHolmens Kanal 7

Copenhagen
1060

Denmark

3Shape UKUK Responsible Person100 Longwater Avenue Green Park

Reading
Berkshire RG2 6GP
UK Responsible Person
England United Kingdom
09/23/202117710
  • Dental CAD/CAM system laboratory :
    • ,
  • Dental treatment application software :
    • ,
  • CAD/CAM software :
3Shape Medical A/SHolmens Kanal 7

Copenhagen
1060

Denmark

3Shape UKUK Responsible Person100 Longwater Avenue Green Park

Reading
Berkshire RG2 6GP
UK Responsible Person
England United Kingdom
09/23/202117712
  • Dental treatment application software :
    • ,
  • Cone beam computed tomography system head/neck :
3Shape Medical A/SHolmens Kanal 7

Copenhagen
1060

Denmark

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202224257
  • Cone beam computed tomography system head/neck :
3Shape TRIOS A/SHolmens Kanal 7

Copenhagen
1060

Denmark

3Shape UKUK Responsible Person100 Longwater Avenue Green Park

Reading
Berkshire RG2 6GP
UK Responsible Person
England United Kingdom
09/23/202117798
  • Intraoral optical scanning system :
    • ,
  • Intraoral optical scanning system :
    • ,
  • Dental CAD/CAM system chairside :
    • ,
  • Intraoral optical scanning system :
3T Medical System Inc.41157 Capital Drive

Canton
Michigan 48187

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/31/202222362
  • Whole-blood-recovery autotransfusion system powered :
4dentPRO GmbH & Co.KGVon Harnack Straße 15

Marburg
35039

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202223028
  • Dental impression material adhesive :
4L Health Co. LtdNo. 108 Dongxin Rd. Dongjiang High-Tech Dist. Huizhou City Guangdong 516000 China

Huizhou
Guangdong 516000

China

Foryou Health Co. Ltd.UK Responsible PersonUnit G25 Waterfront Studios 1 Dock Road London United Kingdom E161AH

London
London E161AH
UK Responsible Person
England United Kingdom
06/27/202215584
  • Negative-pressure wound therapy system dressing set :
    • ,
  • Negative-pressure wound therapy system canister :
    • ,
  • Negative-pressure wound therapy system pump electric : Negative-pressure wound therapy system pump electric Conformity Assessment Certificate Expired
4S Information Systems Ltd trading as 4S DAWN Clinical SoftwareWestmorland House Elmsfield Park

Holme Nr Carnforth
Cumbria LA6 1RJ

England United Kingdom





04/06/20223736
  • Clinical information system web-based application software :
    • ,
  • Clinical management support software :
    • ,
  • Clinical management support software :
4WEB EU B.V.Industrieweg 13b

Assendelft
Noord-Holland 1566 JN

Netherlands

MEDAGENT INTERNATIONAL UK LIMITEDUK Responsible Person2 St Andrews Place

Lewes
East Sussex BN7 1UP
UK Responsible Person
England United Kingdom
04/15/202216125
  • Metallic spinal interbody fusion cage :
    • ,
  • Metallic spinal interbody fusion cage :
    • ,
  • Uncoated ankle talus prosthesis :
    • ,
  • Uncoated ankle talus prosthesis :
6over6 Vision Ltd.6 Simtat Baz St.

Kfar-Saba
47727203

Israel

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
12/21/202120543
  • Automated lensmeter :
    • ,
  • Ophthalmodiastimeter :
    • ,
  • Vision self-testing software :
740 Dental740 Christchurch Road Boscombe

Bournemouth
Dorset BH7 6BZ

United Kingdom





12/02/20155693
  • Assistive nightwear :
76 Dental112 Coleshill Road Water Orton

Birmingham
Warwickshire B46 1RD

United Kingdom





08/23/20198996
  • Temporary dental crown/bridge resin :
77 Elektronika Kft.H-1116 Budapest Fehérvári út 98

Budapest
H-1116

Hungary

A. Menarini Diagnostics Ltd.UK Responsible Person405 Wharfedale Road

Wokingham
Berkshire RG41 5RA
UK Responsible Person
England United Kingdom
03/01/202221409
  • Urine sediment IVD kit spectrophotometry :
    • ,
  • Urine analyser IVD laboratory automated :
    • ,
  • Urine analyser IVD point-of-care :
A - Line Dental ServicesUnit 11 Hepworth Road
North Hylton Enterprise Park
Sunderland
Tyne And Wear SR5 3JT

England United Kingdom





04/05/20221679
  • Dental Appliances/Prostheses :
A C Cossor & Son (Surgical) LtdBlock 1 Annickbank Innovation Campus Annick Road

Irvine
Ayrshire KA11 4LF

Scotland United Kingdom
01279433456
sales@accoson.com





04/10/20226832
  • Aneroid manual sphygmomanometer :
    • ,
  • Manual-inflation electronic sphygmomanometer non-portable :
    • ,
  • Intravenous pressure infusor manual reusable :
    • ,
  • Mechanical stethoscope :
A C DENTAL SERVICES143 Welholme Road

Grimsby
South Humberside DN32 9LN

United Kingdom





06/21/20123970
  • Dental Appliances/Prostheses :
    • ,
  • Overdenture :
    • ,
  • Denture reliner hard :
    • ,
  • Denture reliner soft professional :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Denture clasp polymer preformed :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Partial denture :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implant suprastructure temporary custom-made :
    • ,
  • Dental implantation drilling template custom-made :
    • ,
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Orthodontic clasp metal custom-made :
    • ,
  • Orthodontic clasp metal preformed :
    • ,
  • Orthodontic retainer :
    • ,
  • Orthodontic space maintainer :
    • ,
  • Orthodontic palate expander/teeth aligner bonded :
    • ,
  • Orthodontic palate expander/teeth aligner self-removable :
    • ,
  • Orthodontic habit prevention/breaking appliance self-removable :
    • ,
  • Orthodontic palate expander screw key :
    • ,
  • Orthodontic resin positioning tray :
    • ,
  • Custom-made dental anatomy model :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental impression tray single-use :
    • ,
  • Orthodontic face bow :
    • ,
  • Bite registration rim :
    • ,
  • Bite registration rim wax :
    • ,
  • Bite registration rim wax plate :
    • ,
  • Resin artificial teeth :
    • ,
  • Gold artificial teeth :
    • ,
  • Denture retention spring :
    • ,
  • Orthodontic progressive aligner :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Orthodontic archwire :
A Ceramics Ltd128-132 Manchester Road Shaw

Oldham
Lancashire OL2 7DD

United Kingdom





08/06/20095586
  • Custom-made dental crown ceramic :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental implant abutment analog scanning :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implant suprastructure temporary preformed single-use :
    • ,
  • Dental bridge polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Preformed complete denture :
    • ,
  • Root canal post custom-made :
A D G Dental Services96 Elm Road

New Malden
Surrey KT3 3HN

United Kingdom





04/02/2022214
  • Dental Appliances/Prostheses :
A J Taylor CeramicsThree Arch Office Lawrenny
Kilgetty
Pembs
Pembrokeshire SA680PW

Wales United Kingdom





04/07/20224630
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Dental prosthesis veneer resin :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Root canal post custom-made :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental prosthesis/implant abutment screw :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Resin dental inlay :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Dental bridge ceramic :
A M J Ceramics51A Albion Road Idle

Bradford
West Yorkshire BD10 9QE

United Kingdom





03/17/2003861
  • 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 :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Dental cusp permanent :
    • ,
  • Dental cusp temporary :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental veneer professional :
    • ,
  • Root canal post custom-made :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Orthodontic appliance positioning tray :
    • ,
  • Orthodontic retainer :
A ONE M TRADERS LIMITED216 THE BROADWAY Perry Barr

BIRMINGHAM
B20 3DL

England United Kingdom





09/18/20199076
  • Mouthguard reusable :
A P Cargill Chrome Design LtdUnit B & C The Parkway Centre
Coulby Newham
Coulby Newham
Middlesborough TS8 0TJ

United Kingdom





05/28/20095468
  • Dental Appliances/Prostheses :
    • ,
  • Complete upper denture :
    • ,
  • Complete lower denture :
    • ,
  • Overdenture :
    • ,
  • Denture clasp polymer preformed :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Partial denture :
A Plus Dental Laboratory10 George Buckman Drive Camperdown Ind Park

Dundee
Angus DD2 3SP

United Kingdom





06/03/20081694
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Gold dental inlay :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Ceramic dental inlay :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Dental cusp permanent :
    • ,
  • Dental cusp temporary :
    • ,
  • Resin dental inlay :
    • ,
  • Denture reliner hard :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Dental prosthesis/implant abutment screw :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Dental veneer professional :
    • ,
  • Preformed complete denture :
    • ,
  • Root canal post custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Fluoride gel tray :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Dental mould :
    • ,
  • Dental impression tray reusable :
    • ,
  • Bite registration rim wax :
    • ,
  • Ceramic dental inlay adhesive solution :
    • ,
  • Dental veneer professional :
A R Cooley LTD71 Toys Lane Halesowen

Nr Birmingham
B63 2LB

England United Kingdom





02/02/202222594
  • Complete upper denture :
    • ,
  • Partial denture :
    • ,
  • Mouthguard reusable :
    • ,
  • Custom-made mouthguard :
    • ,
  • Complete lower denture :
A S Dental Lab5 Queen St

Tintinhull
SOMERSET BA22 8PG

United Kingdom





09/27/20199092
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental anatomy model :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Gold dental inlay :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Resin dental inlay :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Ceramic dental inlay :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental veneer professional :
    • ,
  • Sliding dental precision attachment :
    • ,
  • Resilient dental precision attachment :
    • ,
  • Dental implantation drilling template custom-made :
    • ,
  • Dental implant suprastructure temporary custom-made :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental impression tray single-use :
    • ,
  • Orthodontic retainer :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Dental bridge ceramic :
A & A Pretious Dental Laboratory83 Parrock Street

Gravesend
Kent DA12 1HF

United Kingdom





08/25/995105
  • Dental prosthesis veneer resin :
    • ,
  • Bonded dental bridge :
    • ,
  • Ceramic dental inlay :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental veneer professional :
    • ,
  • Dental prosthesis veneer resin :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Denture clasp polymer preformed :
    • ,
  • Gold dental inlay :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Resin dental inlay :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Temporary dental crown/bridge resin :
A & B Cann Dentures Direct Ltd123A Northenden Road Sale Moor

Sale
Cheshire M33 3HF

United Kingdom





04/07/20224508
  • Dental Appliances/Prostheses :
A & W Dental Laboratory Ltd13 Buttermere Avenue

Heywood
Lancashire OL10 2BH

United Kingdom





11/18/20133650
  • Partial denture :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Dental prosthesis bite verification device :
    • ,
  • Dental appliance fabrication material thermoplastic :
    • ,
  • Root canal post custom-made :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture reliner hard :
    • ,
  • Overdenture :
    • ,
  • Denture reliner elastic long-term :
    • ,
  • Dental impression tray reusable :
    • ,
  • Denture reliner soft professional :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Orthodontic progressive aligner :
    • ,
  • Bar dental precision attachment :
    • ,
  • Preformed complete denture :
    • ,
  • Orthodontic appliance system bonded :
    • ,
  • Bite registration rim wax :
    • ,
  • Orthodontic retainer :
    • ,
  • Custom-made mouthguard :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Teeth whitening tray :
    • ,
  • Dental implant suprastructure permanent custom-made :
A1 Aesthetics Laboratory Ltd55 Croxteth Hall Lane Croxteth

Liverpool
Merseyside L11 4SA

United Kingdom





11/03/20144608
  • Complete upper denture :
    • ,
  • Complete lower denture :
    • ,
  • Partial denture :
    • ,
  • Denture reliner soft professional :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge polymer :
    • ,
  • Overdenture :
    • ,
  • Root canal post custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Custom-made mouthguard :
    • ,
  • Denture trial fabrication wax :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Resin dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Dental cusp permanent :
    • ,
  • Denture reliner hard :
A1 Dental Laboratory LTD1A Palm Grove London
W5 4AF
London
W7 2AN

United Kingdom





09/25/20155286
  • Custom-made dental crown ceramic :
    • ,
  • Dental prosthesis veneer resin :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Preformed complete denture :
    • ,
  • Partial denture :
    • ,
  • Overdenture :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Root canal post custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental implant abutment analog scanning :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Resin dental inlay :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Teeth whitening tray :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Bonded dental bridge :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Dental implant suprastructure temporary preformed reusable :
    • ,
  • Dental impression tray single-use :
    • ,
  • Dental prosthesis bite verification device :
    • ,
  • Dental veneer professional :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture reliner elastic long-term :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Denture reliner hard :
    • ,
  • Denture reliner soft professional :
    • ,
  • Bar dental precision attachment :
    • ,
  • Magnetic dental precision attachment :
    • ,
  • Resilient dental precision attachment :
    • ,
  • Sliding dental precision attachment :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Preformed dental crown permanent :
A1 GLOBE SDN. BHD.A1-2 Block A Jalan Haruan 5/9 Pusat Komersial Oakland II 70300 Seremban Negeri Sembilan Malaysia

Seremban
Negeri Sembilan 70300

Malaysia

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

London
W1H 1PJ
UK Responsible Person
United Kingdom
05/22/202114398
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
    • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
A4 Health Group Prosthetics268 Finney Lane Heald Green

Cheadle
Cheshire SK8 3QD

United Kingdom





01/29/20134105
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Partial denture :
    • ,
  • Overdenture :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Orthodontic retainer :
AAA DENTALAB LTD1st Floor Unit 4 Watling Gate 297-303 Edgware Road

London
NW9 6NB

England United Kingdom





02/19/20198496
  • Dental appliance/prosthesis connector :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Ceramic dental inlay :
    • ,
  • Custom-made mouthguard :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Overdenture :
    • ,
  • Orthodontic retainer :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge ceramic :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Denture clasp polymer preformed :
    • ,
  • Dental veneer professional :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Partial denture :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
Aalto Scientific Ltd.230 Technology Pkwy

Eatonton GA
31024

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
09/23/202117759
  • Multiple lipid analyte IVD control :
    • ,
  • Multiple thyroid marker IVD control :
    • ,
  • Multiple anaemia-related analyte IVD control :
    • ,
  • Multiple human hormone IVD control :
    • ,
  • Troponin T IVD control :
    • ,
  • Multiple clinical chemistry protein IVD control :
    • ,
  • Beta-hydroxybutyrate IVD control :
    • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
    • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD control :
    • ,
  • Glycated haemoglobin (HbA1c) IVD control :
    • ,
  • Rheumatoid factor IVD control :
    • ,
  • Parathyroid hormone (PTH) IVD control :
    • ,
  • Glucose IVD control :
    • ,
  • 25-Hydroxy vitamin D3 IVD control :
    • ,
  • Multiple therapeutic drugs/drugs of abuse IVD control :
    • ,
  • Multiple urine analyte IVD control :
    • ,
  • Total bilirubin IVD control :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD control :
    • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
    • ,
  • Multiple tissue-associated protein/tumour marker IVD control :
    • ,
  • Multiple cardiac marker IVD control :
Aaron Optometrists LtdBellway House Woodhorn Road

Ashington
Northumberland NE63 0AE

United Kingdom





04/12/20228347
  • Pre-prescription spectacle lens :
    • ,
  • Prescription spectacle lens custom-made :
    • ,
  • Prescription spectacle lens non-customized :
    • ,
  • Tinted spectacle lens prescription custom-made :
    • ,
  • Tinted spectacle lens prescription standard :
    • ,
  • Tinted non-prescription spectacle lens :
AAT Alber Antriebstechnik GmbHEhestetter Weg 11 72458 Albstadt

Albstadt
Albstadt 72458

Germany

UK RepMed Ltd.UK Responsible PersonWey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT
UK Responsible Person
England United Kingdom
01/31/202222482
  • Wheelchair electric-motor-driven propulsion system :
    • ,
  • Stairclimber :
AAYMED INSTRUMENTSKotli Behram

Sialkot
51310

Pakistan

TSI Quality Certification International LimitedAuthorised Representative (Northern Ireland) UK Responsible PersonSuite 2A Blackthorn House St. Pauls Square Birmingham

Birmingham
B3 1RL
Authorised Representative (Northern Ireland) UK Responsible Person
England United Kingdom
05/05/202223021
  • General-purpose surgical scissors reusable :
    • ,
  • Bandage scissors reusable :
    • ,
  • Laryngoscope handle reusable :
    • ,
  • Laryngoscope blade reusable :
    • ,
  • Vaginal speculum reusable :
    • ,
  • Orthodontic pliers :
    • ,
  • Dental mirror reusable :
    • ,
  • Scalpel handle reusable :
    • ,
  • Manual dental scaler reusable :
    • ,
  • Dressing/utility forceps scissors-like reusable :
    • ,
  • Dental elevator tooth/root :
    • ,
  • Mouth gag support reusable :
    • ,
  • Dental dressing forceps reusable :
    • ,
  • Dressing/utility forceps tweezers-like reusable :
    • ,
  • Nasal speculum reusable :
    • ,
  • ENT probe reusable :
    • ,
  • ENT suction dissector :
    • ,
  • Rubber dam clamp :
    • ,
  • Rubber dam clamp forceps :
    • ,
  • Dental explorer :
    • ,
  • Orthodontic metal band pusher :
    • ,
  • Dental irrigation/aspiration syringe :
    • ,
  • Dental impression tray reusable :
    • ,
  • Instrument tray reusable :
    • ,
  • Wire holding/twisting pliers :
    • ,
  • Dental surgical scissors :
    • ,
  • Episiotomy scissors reusable :
    • ,
  • Gynaecological scissors reusable :
    • ,
  • Neurosurgical scissors :
    • ,
  • Ophthalmic strabismus scissors :
    • ,
  • Orthopaedic joint/limb rongeur :
    • ,
  • Orthopaedic knife :
    • ,
  • Tuning fork :
    • ,
  • Bone hook :
    • ,
  • Ear speculum reusable :
    • ,
  • Bone curette reusable :
    • ,
  • Tongue depressor examination reusable :
    • ,
  • Dental articulator :
    • ,
  • Nail extraction forceps :
    • ,
  • Nail scissors reusable :
AB GermaIndustrigatan 54 - 56

Kristianstad
SE-291 36

Sweden

Ferno (UK) LimitedUK Responsible PersonFerno House Stubs Beck Lane West 26 Industrial Estate

Cleckheaton
West Yorkshire BD19 4TZ
UK Responsible Person
United Kingdom
01/13/202221224
  • Vacuum-mould patient positioning system :
    • ,
  • Patient transfer sliding mat :
AB Medica Group S.A.Llobateras 14-18 Talleres 7 Nave 4 Polígono Industrial Salvatella

Barberà del Vallès
Barcelona 8210

Spain

Neoventa Medical Ltd UK Responsible Person34 Anyards Road

Cobham
Surrey KT 11 2LA
UK Responsible Person
England United Kingdom
regulatory@neoventa.com		12/22/202121450
  • Echocardiographic recording paper :
ab medica s.p.a.via J.F. Kennedy 10/12 - 20023 Cerro Maggiore (Ml)

10/12 - 20023 Cerro Maggiore (Ml)
20023

Italy

Compliance Solutions (Lifesciences) LtdUK Responsible PersonSuite 10 Dunswood House 1 Dunswood Road
Cumbernauld
Glasgow
G67 3EN
UK Responsible Person
United Kingdom
02/01/202222359
  • Operating table non-slip back pad :
AB Sciex Pte. Ltd.33 Marsiling Industrial Estate Road 3 #04-06

Woodlands
739256

Singapore

Leica Microsystems (UK) LimitedUK Responsible PersonLothbury House Newmarket Road

Cambridge
CB5 8PB
UK Responsible Person
England United Kingdom
12/10/202120481
  • Mass spectrometry analyser IVD semi-automated :
Abacus DiagnosticaTykistökatu 4D

Turku
FI-20520

Finland

Launch Diagnostics LimitedUK Responsible PersonAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD
UK Responsible Person
United Kingdom
01/18/202221303
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
    • ,
  • Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Norovirus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Streptococcus pneumoniae nucleic acid IVD kit nucleic acid technique (NAT) :
Abanza Tecnomed S.L.Calle Nueva 8 Oficina 11
31192 Aranguren
Navarra
Spain

Spain

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

Talbot Green
Rhondda Cynon Taff CF72 9FG
UK Responsible Person
Wales United Kingdom
04/27/202113987
  • Tendon/ligament bone anchor non-bioabsorbable :
    • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
    • ,
  • Orthopaedic implant inserter/extractor reusable :
    • ,
  • Surgical countersink reusable :
    • ,
  • Orthopaedic implantation sleeve reusable :
    • ,
  • Bone awl reusable :
    • ,
  • Orthopaedic reamer guide :
    • ,
  • Surgical drill guide reusable :
    • ,
  • Surgical mallet :
    • ,
  • Surgical screwdriver reusable :
    • ,
  • Surgical instrument handle non-torque-limiting :
    • ,
  • Instrument tray reusable :
Abatron Limited24 Chapel Street

Sandy
Bedfordshire SG19 2PT

England United Kingdom
01767 261333
info@abatronltd.com





05/24/202114920
  • Contact lens protein-removal solution :
    • ,
  • Contact lens rinsing solution :
    • ,
  • Multi-purpose soft/rigid contact lens solution :
ABBEY GRANGE DENTAL LABORATORY37 Grange Road

Shrewsbury
Shropshire SY3 9DG

United Kingdom





04/07/20224617
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Preformed complete denture :
    • ,
  • Root canal post custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implantation drilling template custom-made :
    • ,
  • Dental prosthesis/implant abutment screw analog reusable :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Dental implant x-ray template :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental veneer professional :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental base plate :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge ceramic :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown ceramic :
Abbey Laboratory Ltd80 Causeyside Street 80 CauseySide St

Paisley
Renfrewshire PA1 1YP

United Kingdom





04/03/2022836
  • Complete upper denture :
    • ,
  • Complete lower denture :
    • ,
  • Partial denture :
    • ,
  • Custom-made mouthguard :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture clasp metal preformed :
Abbeygate Dental Laboratory LtdSuit 12 Manchester House 113 Northgate Street

Bury St. Edmunds
Suffolk IP33 1HP

United Kingdom





11/03/20166134
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Dental bridge polymer :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Custom-made mouthguard :
    • ,
  • Orthodontic retainer :
    • ,
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Root canal post custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Denture reliner hard :
    • ,
  • Denture reliner soft professional :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Dental veneer professional :
    • ,
  • Custom-made dental crown ceramic :
Abbot Dental Laboratory14 Knowles Hill Road

Newton Abbot
TQ12 2PW

England United Kingdom





04/09/20225832
  • Dental Appliances/Prostheses :
Abbott Dental Laboratory12-14 King Street

Bacup
Lancashire OL13 0AH

England United Kingdom





12/31/20133799
  • Dental Appliances/Prostheses :
    • ,
  • Bonded dental bridge :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Gold dental inlay :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
    • ,
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Teeth whitening tray :
    • ,
  • Temporary dental crown/bridge :
Abbott Diabetes Care LtdRange Road

Witney
OX290YL

England United Kingdom





10/31/20199196
  • Home healthcare information system application software :
    • ,
  • Home healthcare information system application software :
    • ,
  • Diabetes patient management software IVD :
    • ,
  • Percutaneous interstitial-fluid glucose monitoring system electrochemical :
    • ,
  • Glucose IVD control :
    • ,
  • Glucose monitoring system IVD home-use :
    • ,
  • Glucose/ketone monitoring system IVD home-use :
    • ,
  • Glucose/ketone monitoring system IVD home-use :
    • ,
  • Percutaneous interstitial-fluid glucose monitoring system electrochemical :
    • ,
  • Percutaneous interstitial-fluid glucose monitoring system electrochemical :
    • ,
  • Self-care monitoring/reporting software :
    • ,
  • Percutaneous interstitial-fluid glucose monitoring system electrochemical :
    • ,
  • Percutaneous interstitial-fluid glucose monitoring system electrochemical :
    • ,
  • Diabetes patient management software IVD :
    • ,
  • Clinical laboratory information system application software :
Abbott Diagnostics Korea Inc.65
Borahagal-Ro Giheung-Gu
Gyeonggi-Do
Yongin-Si 17099

South Korea

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
03/30/202113027
  • Hepatitis C virus total antibody IVD kit rapid ICT clinical :
    • ,
  • HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test :
    • ,
  • HIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinical :
    • ,
  • Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
    • ,
  • Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
    • ,
  • Dengue virus NS1 antigen IVD kit rapid ICT clinical :
    • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • Plasmodium falciparum antigen IVD kit immunochromatographic test (ICT) :
    • ,
  • Rotavirus antigen IVD kit rapid ICT clinical :
    • ,
  • Vibrio cholerae antigen (multiple serotype) IVD kit rapid ICT clinical :
    • ,
  • Treponema pallidum total antibody IVD kit rapid ICT clinical :
    • ,
  • Multiple Leptospira species immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
    • ,
  • Adenovirus antigen IVD kit rapid ICT clinical :
    • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
    • ,
  • Norovirus antigen IVD kit rapid ICT clinical :
    • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
    • ,
  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
Abbott Diagnostics Medical Co. Ltd.357 Matsuhidai Matsudo-shi

Chiba
270-2214

Japan

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
04/19/202113507
  • HIV1/HIV2 antigen/antibody IVD kit rapid ICT clinical :
    • ,
  • HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test :
    • ,
  • Hepatitis B virus surface antigen IVD kit rapid ICT clinical :
    • ,
  • HIV1/HIV2 antigen/antibody IVD control :
    • ,
  • Treponema pallidum total antibody IVD kit rapid ICT clinical :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
    • ,
  • Capillary blood collection tube IVD K2EDTA :
    • ,
  • Buffered isotonic saline reagent IVD :
Abbott Diagnostics Scarborough Inc.10 Southgate Rd

Scarborough
Maine 04074

United States

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
07/08/202115830
  • Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical :
    • ,
  • Multiple Plasmodium species antigen IVD control :
    • ,
  • General specimen collection kit IVD clinical :
    • ,
  • SARS-CoV-2 nucleic acid IVD control :
    • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Immunoassay reagent vehicle tray IVD reusable :
    • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
    • ,
  • Nuclear matrix protein 22 IVD reagent :
    • ,
  • Wuchereria bancrofti antigen IVD kit rapid ICT clinical :
    • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
    • ,
  • Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Influenza A/B virus nucleic acid IVD control :
    • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
    • ,
  • Influenza A/B virus antigen IVD control :
    • ,
  • Respiratory syncytial virus (RSV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Legionella pneumophila antigen IVD kit rapid ICT clinical :
    • ,
  • Legionella pneumophila antigen IVD kit enzyme immunoassay (EIA) :
    • ,
  • Legionella pneumophila antigen IVD control :
    • ,
  • Legionella pneumophila antigen IVD reagent :
    • ,
  • Beta-haemolytic Group A Streptococcus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Beta-haemolytic Group A Streptococcus nucleic acid IVD control :
    • ,
  • Streptococcus pneumoniae antigen IVD kit rapid ICT clinical :
    • ,
  • Streptococcus pneumoniae antigen IVD control :
    • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit rapid ICT clinical :
    • ,
  • Nuclear matrix protein 22 IVD kit enzyme immunoassay (EIA) :
    • ,
  • Nuclear matrix protein 22 IVD kit rapid ICT clinical :
    • ,
  • Nuclear matrix protein 22 IVD control :
    • ,
  • Isothermal nucleic acid amplification analyser IVD laboratory semi-automated :
    • ,
  • Respiratory syncytial virus (RSV) antigen IVD control :
    • ,
  • Respiratory syncytial virus (RSV) nucleic acid IVD control :
    • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD control :
    • ,
  • Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinical :
    • ,
  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD kit :
    • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
    • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
    • ,
  • Protease IVD kit rapid ICT clinical :
Abbott Diagnostics Technologies ASKjelsasveien 161 P.O. Box 6863 Rodelokka

Oslo
NO-0504

Norway

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
07/29/202116309
  • Multiple lipid analyte IVD control :
    • ,
  • Capillary blood collection tube IVD no additive :
    • ,
  • C-reactive protein (CRP) IVD control :
    • ,
  • Glycated haemoglobin (HbA1c) IVD control :
    • ,
  • Multiple lipid analyte IVD reagent :
    • ,
  • C-reactive protein (CRP) IVD reagent :
    • ,
  • Single-channel clinical chemistry analyser IVD point-of-care :
    • ,
  • Microalbumin IVD control :
    • ,
  • Microalbumin IVD reagent :
    • ,
  • Glycated haemoglobin (HbA1c) IVD reagent :
Abbott GmbHMax-Planck-Ring 2

Wiesbaden
65205

Germany

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202212352
  • Treponema pallidum total antibody IVD control :
    • ,
  • Treponema pallidum total antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Trypanosoma cruzi total antibody IVD calibrator :
    • ,
  • Trypanosoma cruzi total antibody IVD control :
    • ,
  • Des-gamma-carboxyprothrombin (DCP) IVD calibrator :
    • ,
  • Des-gamma-carboxyprothrombin (DCP) IVD control :
    • ,
  • Des-gamma-carboxyprothrombin (DCP) IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Insulin IVD calibrator :
    • ,
  • Insulin IVD control :
    • ,
  • Insulin IVD kit chemiluminescent immunoassay :
    • ,
  • Total testosterone IVD calibrator :
    • ,
  • Total testosterone IVD control :
    • ,
  • Total testosterone IVD kit chemiluminescent immunoassay :
    • ,
  • 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 :
    • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Parathyroid hormone (PTH) IVD calibrator :
    • ,
  • Parathyroid hormone (PTH) IVD control :
    • ,
  • Parathyroid hormone (PTH) IVD kit chemiluminescent immunoassay :
    • ,
  • Chemiluminescent immunoassay analyser IVD automated :
    • ,
  • Cancer antigen 19-9 (CA19-9) IVD calibrator :
    • ,
  • Cancer antigen 19-9 (CA19-9) IVD control :
    • ,
  • Cancerantigen19-9 (CA19-9) IVD kit chemiluminescent immunoassay :
    • ,
  • Cancer antigen 125 (CA125) IVD calibrator :
    • ,
  • Cancer antigen 125 (CA125) IVD control :
    • ,
  • Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassay :
    • ,
  • Human epididymis protein 4 (HE4) IVD calibrator :
    • ,
  • Human epididymis protein 4 (HE4) IVD control :
    • ,
  • Human epididymis protein 4 (HE4) IVD kit chemiluminescent immunoassay :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD calibrator :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD control :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassay :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Pepsinogen I IVD calibrator :
    • ,
  • Pepsinogen I IVD control :
    • ,
  • Pepsinogen I IVD kit chemiluminescent immunoassay :
    • ,
  • Pepsinogen II IVD calibrator :
    • ,
  • PepsinogenII IVD kit chemiluminescent immunoassay :
    • ,
  • Vitamin B12 IVD calibrator :
    • ,
  • Vitamin B12 IVD control :
    • ,
  • Vitamin B12 IVD kit chemiluminescent immunoassay :
    • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD calibrator :
    • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD control :
    • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD kit chemiluminescent immunoassay :
    • ,
  • Homocysteine IVD calibrator :
    • ,
  • Homocysteine IVD control :
    • ,
  • HomocysteineIVD kit chemiluminescent immunoassay :
    • ,
  • Progastrin-releasing peptide (ProGRP) IVD calibrator :
    • ,
  • Progastrin-releasing peptide (ProGRP) IVD control :
    • ,
  • Progastrin-releasing peptide (ProGRP) IVD kit chemiluminescent immunoassay :
    • ,
  • Squamous cell carcinoma antigen IVD calibrator :
    • ,
  • Squamous cell carcinoma antigen IVD control :
    • ,
  • Squamous cell carcinoma antigen IVD kit chemiluminescent immunoassay :
    • ,
  • C-peptide IVD calibrator :
    • ,
  • C-peptide IVD control :
    • ,
  • C-peptide IVD kit chemiluminescent immunoassay :
    • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD calibrator :
    • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD control :
    • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD kit chemiluminescent immunoassay :
    • ,
  • Sex hormone binding globulin (SHBG) IVD calibrator :
    • ,
  • Sex hormone binding globulin (SHBG) IVD control :
    • ,
  • Sex hormone binding globulin (SHBG) IVD kit chemiluminescent immunoassay :
    • ,
  • Cytokeratin IVD calibrator :
    • ,
  • Cytokeratin IVD control :
    • ,
  • Cytokeratin IVD kit chemiluminescent immunoassay :
    • ,
  • Methotrexate therapeutic drug monitoring IVD calibrator :
    • ,
  • Methotrexate therapeutic drug monitoring IVD control :
    • ,
  • Methotrexate therapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Galectin-3 IVD calibrator :
    • ,
  • Galectin-3 IVD control :
    • ,
  • Galectin-3 IVD kit chemiluminescent immunoassay :
    • ,
  • Neuron-specific enolase (NSE) IVD calibrator :
    • ,
  • Neuron-specific enolase (NSE) IVD control :
    • ,
  • Neuron-specific enolase (NSE) IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroglobulin IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroglobulin IVD calibrator :
    • ,
  • Thyroglobulin IVD control :
    • ,
  • Haematological cell analyser IVD automated :
    • ,
  • Buffered sample diluent IVD automated/semi-automated system :
    • ,
  • Full blood count IVD control :
    • ,
  • Full blood count IVD calibrator :
    • ,
  • Microscope slide maker/stainer IVD automated :
    • ,
  • General specimen microscopy slide IVD single-use :
    • ,
  • Reagent grade alcohol solution IVD :
    • ,
  • Biological stain IVD :
    • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
    • ,
  • Plasma protein IVD calibrator :
    • ,
  • Prealbumin (transthyretin) IVD calibrator :
    • ,
  • Iron IVD calibrator :
    • ,
  • Total bilirubin IVD kit spectrophotometry :
    • ,
  • Total protein IVD reagent :
    • ,
  • Buffered sample diluent IVD manual :
    • ,
  • Glucose IVD kit enzyme spectrophotometry :
    • ,
  • Calcium (Ca2+) IVD kit spectrophotometry :
    • ,
  • Total amylase IVD reagent :
    • ,
  • Total microprotein IVD kit nephelometry/turbidimetry :
    • ,
  • Carbon dioxide (CO2) IVD kit spectrophotometry :
    • ,
  • Gamma-glutamyltransferase (GGT) IVD reagent :
    • ,
  • Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometry :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD reagent :
    • ,
  • Total cholesterol lipid IVD reagent :
    • ,
  • Triglyceride IVD reagent :
    • ,
  • Conjugated (direct) bilirubin IVD reagent :
    • ,
  • Alanine aminotransferase (ALT) IVD reagent :
    • ,
  • Creatinine IVD kit spectrophotometry :
    • ,
  • Albumin IVD reagent :
    • ,
  • Microalbumin IVD calibrator :
    • ,
  • Microalbumin IVD control :
    • ,
  • Microalbumin IVD kit nephelometry/turbidimetry :
    • ,
  • Urea IVD reagent :
    • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
    • ,
  • Magnesium (Mg2+) IVD kit spectrophotometry :
    • ,
  • Total alkaline phosphatase (ALP) IVD reagent :
    • ,
  • Lactate IVD kit reduction/oxidation :
    • ,
  • Total aspartate aminotransferase (AST) IVD reagent :
    • ,
  • Transferrin IVD kit nephelometry/turbidimetry :
    • ,
  • Inorganic phosphate (PO43-) IVD reagent :
    • ,
  • Total creatine kinase (CK) IVD reagent :
    • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
    • ,
  • Glycated haemoglobin (HbA1c) IVD control :
    • ,
  • Glycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetry :
    • ,
  • Uric acid IVD kit enzyme spectrophotometry :
    • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
    • ,
  • Total bilirubin IVD calibrator :
    • ,
  • Multiple electrolyte IVD calibrator :
    • ,
  • Total microprotein IVD calibrator :
    • ,
  • Carbon dioxide (CO2) IVD calibrator :
    • ,
  • Ion selective electrode (ISE) reference solution IVD reagent :
    • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
    • ,
  • Multiple lipid analyte IVD calibrator :
    • ,
  • Apolipoprotein A-I (Apo A1) IVD reagent :
    • ,
  • Apolipoprotein B (Apo B) IVD reagent :
    • ,
  • Complement components C3/C3c IVD reagent :
    • ,
  • Complement components C4/C4c IVD reagent :
    • ,
  • Haptoglobin IVD reagent :
    • ,
  • Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetry :
    • ,
  • Immunoglobulin G subclass (IgG subclass) IVD kit nephelometry/turbidimetry :
    • ,
  • Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetry :
    • ,
  • Prealbumin (transthyretin) IVD kit nephelometry/turbidimetry :
    • ,
  • Theophylline therapeutic drug monitoring IVD calibrator :
    • ,
  • Theophyllinetherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Vancomycin therapeutic drug monitoring IVD calibrator :
    • ,
  • Vancomycintherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Gentamicin therapeutic drug monitoring IVD calibrator :
    • ,
  • Gentamicintherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Carbamazepine therapeutic drug monitoring IVD calibrator :
    • ,
  • Carbamazepinetherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Procalcitonin (PCT) IVD calibrator :
    • ,
  • Procalcitonin (PCT) IVD control :
    • ,
  • Procalcitonin (PCT) IVD kit chemiluminescent immunoassay :
    • ,
  • Chemiluminescent immunoassay oxidizing reagent IVD :
    • ,
  • Multiple blood-borne virus antigen/antibody IVD control :
    • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassay :
    • ,
  • Treponema pallidum total antibody IVD calibrator :
    • ,
  • Trypanosoma cruzi total antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Pepsinogen II IVD control :
    • ,
  • Buffered wash solution IVD automated/semi-automated system :
    • ,
  • MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • MDR-TB/XDR-TB nucleic acid IVD control :
    • ,
  • Laboratory instrument/analyser application software IVD :
    • ,
  • Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Mycobacterium tuberculosis nucleic acid IVD control :
    • ,
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD control :
    • ,
  • Deionization water purification system :
    • ,
  • Microscope slide labelling cartridge IVD :
    • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD control :
    • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassay :
    • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD control :
    • ,
  • HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassay :
    • ,
  • HIV1/HIV2 antigen/antibody IVD calibrator :
    • ,
  • HIV1/HIV2 antigen/antibody IVD control :
    • ,
  • Hepatitis C virus total antibody IVD calibrator :
    • ,
  • Hepatitis C virus total antibody IVD control :
    • ,
  • Hepatitis C virus total antibody IVD kit chemiluminescent assay :
    • ,
  • Hepatitis B virus core total antibody IVD control :
    • ,
  • Hepatitis B virus core total antibody IVD calibrator :
    • ,
  • Hepatitis B virus e-antigen IVD calibrator :
    • ,
  • Hepatitis B virus e-antigen IVD control : Hepatitis B virus e-antigen IVD control Conformity Assessment Certificate Expired
    • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis B virus e-antigen total antibody IVD calibrator :
    • ,
  • Hepatitis B virus e-antigen total antibody IVD control :
    • ,
  • Hepatitis B virus e-antigen total antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis B virus e-antigen IVD kit chemiluminescent immunoassay : Hepatitis B virus e-antigen IVD kit chemiluminescent immunoassay Conformity Assessment Certificate Expired
    • ,
  • Hepatitis C virus core antigen IVD control :
    • ,
  • Hepatitis C virus core antigen IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis B virus core total antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis C virus core antigen IVD calibrator : Hepatitis C virus core antigen IVD calibrator Conformity Assessment Certificate Expired
    • ,
  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD calibrator : Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD calibrator Conformity Assessment Certificate Expired
    • ,
  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD control : Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD control Conformity Assessment Certificate Expired
Abbott Ireland Diagnostics DivisionFinisklin Business Park

Sligo
n/a

Ireland

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202212578
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD control :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD kit chemiluminescent immunoassay :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Total prostate specific antigen (tPSA) IVD calibrator :
    • ,
  • Total prostate specific antigen (tPSA) IVD control :
    • ,
  • Total prostate specific antigen (tPSA) IVD kit chemiluminescent immunoassay :
    • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD calibrator :
    • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD control :
    • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD kit chemiluminescent immunoassay :
    • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Rubellavirus immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD control :
    • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Chemiluminescent immunoassay oxidizing reagent IVD :
    • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibrator :
    • ,
  • Cyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibrator :
    • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassay :
    • ,
  • Multiple thyroid antibody IVD control :
    • ,
  • Multiple thyroid antibody IVD calibrator :
    • ,
  • Thyroglobulin antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroglobulin antibody IVD control :
    • ,
  • Thyroglobulin antibody IVD calibrator :
    • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD control :
    • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Chemiluminescent immunoassay signal generation kit IVD :
    • ,
  • Thyroid stimulating hormone receptor (TSHR) antibody IVD control :
    • ,
  • Thyroid stimulating hormone receptor (TSHR) antibody IVD calibrator :
    • ,
  • Thyroid stimulating hormone receptor (TSHR) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Cancer antigen 72-4 (CA 72-4) IVD kit chemiluminescent immunoassay :
    • ,
  • Cancer antigen 72-4 (CA72-4) IVD control :
    • ,
  • Cancer antigen 72-4 (CA72-4) IVD calibrator :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Total cortisol IVD kit chemiluminescent immunoassay :
    • ,
  • Total cortisol IVD calibrator :
    • ,
  • Myoglobin IVD kit chemiluminescent immunoassay :
    • ,
  • Myoglobin IVD control :
    • ,
  • Myoglobin IVD calibrator :
    • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
    • ,
  • Procalcitonin (PCT) IVD kit chemiluminescent immunoassay :
    • ,
  • Procalcitonin (PCT) IVD control :
    • ,
  • Procalcitonin (PCT) IVD calibrator :
    • ,
  • Phosphate buffer/Sorenson buffer solution IVD :
    • ,
  • White blood cell count IVD kit cell count :
    • ,
  • Reticulocyte count IVD kit cell count :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
    • ,
  • Thyroid uptake (T-uptake) IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroid uptake (T-uptake) IVD control :
    • ,
  • Thyroid uptake (T-uptake) IVD calibrator :
    • ,
  • Alpha-fetoprotein (AFP) IVD kit chemiluminescent immunoassay :
    • ,
  • Alpha-fetoprotein (AFP) IVD control :
    • ,
  • Alpha-fetoprotein (AFP) IVD calibrator :
    • ,
  • Carcinoembryonic antigen (CEA) IVD kit chemiluminescent immunoassay :
    • ,
  • Carcinoembryonic antigen (CEA) IVD control :
    • ,
  • Carcinoembryonic antigen (CEA) IVD calibrator :
    • ,
  • Creatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassay :
    • ,
  • Blood cell lysis reagent IVD :
    • ,
  • Buffered sample diluent IVD manual :
    • ,
  • Buffered wash solution IVD automated/semi-automated system :
    • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Hepatitis B virus surface antigen IVD calibrator :
    • ,
  • Hepatitis B virus surface antigen IVD control :
    • ,
  • Hepatitis B virus surface antigen IVD kit chemiluminescent immunoassay :
    • ,
  • Hepatitis B virus surface total antibody IVD calibrator :
    • ,
  • Hepatitis B virus surface total antibody IVD control :
    • ,
  • Hepatitis B virus surface total antibody IVD kit chemiluminescent immunoassay :
Abbott Ireland Diagnostics DivisionLisnamuck Longford Co. Longford

Longford
na

Ireland

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202218638
  • Progesterone IVD control :
    • ,
  • Progesterone IVD kit chemiluminescent immunoassay :
    • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD calibrator :
    • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD control :
    • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit chemiluminescent immunoassay :
    • ,
  • Total amylase IVD reagent :
    • ,
  • Folate (vitamin B9) IVD control :
    • ,
  • Transferrin IVD kit nephelometry/turbidimetry :
    • ,
  • Albumin IVD reagent :
    • ,
  • Immunoglobulin G subclass (IgG subclass) IVD kit nephelometry/turbidimetry :
    • ,
  • Total cholesterol lipid IVD reagent :
    • ,
  • Complement components C3/C3c IVD reagent :
    • ,
  • Apolipoprotein B (Apo B) IVD reagent :
    • ,
  • Apolipoprotein A-I (Apo A1) IVD reagent :
    • ,
  • Total aspartate aminotransferase (AST) IVD reagent :
    • ,
  • Triglyceride IVD reagent :
    • ,
  • Urea IVD reagent :
    • ,
  • Complement components C4/C4c IVD reagent :
    • ,
  • Magnesium (Mg2+) IVD kit spectrophotometry :
    • ,
  • Uric acid IVD kit enzyme spectrophotometry :
    • ,
  • Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetry :
    • ,
  • Prealbumin (transthyretin) IVD kit nephelometry/turbidimetry :
    • ,
  • Rheumatoid factor IVD kit nephelometry/turbidimetry :
    • ,
  • Total bilirubin IVD kit spectrophotometry :
    • ,
  • Multiple vitamin IVD calibrator :
    • ,
  • Multiple vitamin IVD control :
    • ,
  • Multiple form 25-hydroxy vitamin D IVD kit chemiluminescent immunoassay :
    • ,
  • Neutrophil gelatinase-associated lipocalin (NGAL) IVD calibrator :
    • ,
  • Neutrophil gelatinase-associated lipocalin (NGAL) IVD control :
    • ,
  • Neutrophil gelatinase-associated lipocalin (NGAL) IVD kit chemiluminescent immunoassay :
    • ,
  • Folate (vitamin B9) IVD calibrator :
    • ,
  • Folate(vitamin B9) IVD kit chemiluminescent immunoassay :
    • ,
  • Folate (vitamin B9) IVD reagent :
    • ,
  • Buffered sample diluent IVD manual :
    • ,
  • Luteinizing hormone (LH) IVD calibrator :
    • ,
  • Luteinizing hormone (LH) IVD kit chemiluminescent immunoassay :
    • ,
  • Troponin I IVD calibrator :
    • ,
  • Troponin I IVD control :
    • ,
  • Troponin I IVD kit chemiluminescent immunoassay :
    • ,
  • Ferritin IVD calibrator :
    • ,
  • Ferritin IVD control :
    • ,
  • FerritinIVD kit chemiluminescent immunoassay :
    • ,
  • Vitamin B12 IVD calibrator :
    • ,
  • Vitamin B12 IVD control :
    • ,
  • Vitamin B12 IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroid stimulating hormone (TSH) IVD calibrator :
    • ,
  • Thyroid stimulating hormone (TSH) IVD control :
    • ,
  • Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassay :
    • ,
  • Free triiodothyronine (FT3) IVD calibrator :
    • ,
  • Free triiodothyronine (FT3) IVD control :
    • ,
  • Free triiodothyronine (FT3) IVD kit chemiluminescent immunoassay :
    • ,
  • Total triiodothyronine (TT3) IVD calibrator :
    • ,
  • Total triiodothyronine (TT3) IVD kit chemiluminescent immunoassay :
    • ,
  • Free thyroxine (FT4) IVD calibrator :
    • ,
  • Free thyroxine (FT4) IVD control :
    • ,
  • Free thyroxine (FT4) IVD kit chemiluminescent immunoassay :
    • ,
  • Total thyroxine (TT4) IVD calibrator :
    • ,
  • Total thyroxine (TT4) IVD control :
    • ,
  • Total thyroxine (TT4) IVD kit chemiluminescent immunoassay :
    • ,
  • Estradiol (oestradiol) (E2) IVD calibrator :
    • ,
  • Estradiol (oestradiol) (E2) IVD control :
    • ,
  • Estradiol(oestradiol) (E2) IVD kit chemiluminescent immunoassay :
    • ,
  • Follicle stimulating hormone (FSH) IVD calibrator :
    • ,
  • Follicle stimulating hormone (FSH) IVD control :
    • ,
  • Follicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassay :
    • ,
  • Prolactin IVD calibrator :
    • ,
  • Prolactin IVD control :
    • ,
  • Prolactin IVD kit chemiluminescent immunoassay :
    • ,
  • Progesterone IVD calibrator :
    • ,
  • Alanine aminotransferase (ALT) IVD reagent :
    • ,
  • Creatinine IVD kit spectrophotometry :
    • ,
  • Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetry :
    • ,
  • Haptoglobin IVD reagent :
    • ,
  • Total alkaline phosphatase (ALP) IVD reagent :
    • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
    • ,
  • Gamma-glutamyltransferase (GGT) IVD reagent :
    • ,
  • Total bilirubin IVD kit spectrophotometry :
    • ,
  • Total protein IVD reagent :
    • ,
  • Iron IVD kit enzyme spectrophotometry :
    • ,
  • Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometry :
    • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
Abbott IrelandCarbury Point Finiskilin Business & Technology Park
Sligo
County Sligo
F91 N2A4

Ireland

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202219654
  • Enteral feeding noninvasive-component set :
    • ,
  • Enteral feeding bag/bottle :
    • ,
  • Enteral feeding pole :
    • ,
  • Hepatitis B virus surface total antibody IVD reagent :
    • ,
  • Hepatitis B virus surface total antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD calibrator :
    • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD control :
    • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit chemiluminescent immunoassay :
Abbott Laboratories Santa Clara4551 Great America Parkway

Santa Clara
CA 95054

United States

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202222929
  • Deionization water purification system :
    • ,
  • Buffered wash solution IVD automated/semi-automated system :
    • ,
  • Buffered sample diluent IVD automated/semi-automated system :
    • ,
  • White blood cell count IVD kit cell count :
    • ,
  • Reticulocyte count IVD kit cell count :
    • ,
  • Blood cell lysis reagent IVD :
    • ,
  • Phosphate buffer/Sorenson buffer solution IVD :
    • ,
  • Reagent grade alcohol solution IVD :
    • ,
  • Microscope slide maker/stainer IVD automated :
    • ,
  • Microscope slide labelling cartridge IVD :
    • ,
  • Blood smearing cassette IVD :
    • ,
  • General specimen microscopy slide IVD single-use :
    • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
    • ,
  • Haematological cell analyser IVD automated :
    • ,
  • Full blood count IVD control :
    • ,
  • Full blood count IVD calibrator :
    • ,
  • Reticulocyte count IVD control :
    • ,
  • T lymphocyte IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
    • ,
  • Platelet count IVD kit cell count :
    • ,
  • Deionization water purification system :
    • ,
  • Biological stain IVD :
Abbott LaboratoriesLake County Site 100 Abbott Park Road Abbott Park

Illinois
Illinois 60064

United States

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202219226
  • C-peptide IVD control :
    • ,
  • C-peptide IVD kit chemiluminescent immunoassay :
    • ,
  • Insulin IVD calibrator :
    • ,
  • Insulin IVD control :
    • ,
  • Insulin IVD kit chemiluminescent immunoassay :
    • ,
  • Buffered sample diluent IVD automated/semi-automated system :
    • ,
  • Reticulocyte count IVD kit cell count :
    • ,
  • White blood cell count IVD kit cell count :
    • ,
  • Haematological cell analyser IVD automated :
    • ,
  • Platelet count IVD kit cell count :
    • ,
  • Microscope slide maker IVD :
    • ,
  • T lymphocyte IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
    • ,
  • Laboratory instrument/analyser application software IVD :
    • ,
  • Full blood count IVD calibrator :
    • ,
  • Full blood count IVD control :
    • ,
  • Reticulocyte count IVD control :
    • ,
  • Total creatine kinase (CK) IVD reagent :
    • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
    • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
    • ,
  • Chemiluminescent immunoassay analyser IVD automated :
    • ,
  • Multiple lipid analyte IVD calibrator :
    • ,
  • Buffered wash solution IVD automated/semi-automated system :
    • ,
  • Prealbumin (transthyretin) IVD calibrator :
    • ,
  • Blood cell lysis reagent IVD :
    • ,
  • Rapamycin (sirolimus) therapeutic drug monitoring IVD calibrator :
    • ,
  • Rapamycin(sirolimus) therapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Rapamycin (sirolimus) therapeutic drug monitoring IVD reagent :
    • ,
  • Tacrolimus therapeutic drug monitoring IVD calibrator :
    • ,
  • Tacrolimustherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Tacrolimus therapeutic drug monitoring IVD reagent :
    • ,
  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD reagent :
    • ,
  • Carbon dioxide (CO2) IVD calibrator :
    • ,
  • Calcium (Ca2+) IVD kit spectrophotometry :
    • ,
  • Creatinine IVD kit spectrophotometry :
    • ,
  • Magnesium (Mg2+) IVD kit spectrophotometry :
    • ,
  • Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetry :
    • ,
  • Prealbumin (transthyretin) IVD kit nephelometry/turbidimetry :
    • ,
  • Transferrin IVD kit nephelometry/turbidimetry :
    • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
    • ,
  • Multiple electrolyte IVD calibrator :
    • ,
  • Ion selective electrode (ISE) reference solution IVD reagent :
    • ,
  • Total bilirubin IVD calibrator :
    • ,
  • Plasma protein IVD calibrator :
    • ,
  • Buffered sample diluent IVD manual :
    • ,
  • Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometry :
    • ,
  • Lipase IVD calibrator :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD reagent :
    • ,
  • Carbon dioxide (CO2) IVD kit spectrophotometry :
    • ,
  • Glucose IVD kit enzyme spectrophotometry :
    • ,
  • Uric acid IVD kit enzyme spectrophotometry :
    • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
    • ,
  • Glycated haemoglobin (HbA1c) IVD control :
    • ,
  • Glycated haemoglobin (HbA1c) IVD kit nephelometry/turbidimetry :
    • ,
  • Total bilirubin IVD kit spectrophotometry :
    • ,
  • Albumin IVD reagent :
    • ,
  • Total alkaline phosphatase (ALP) IVD reagent :
    • ,
  • Alanine aminotransferase (ALT) IVD reagent :
    • ,
  • Total amylase IVD reagent :
    • ,
  • Gamma-glutamyltransferase (GGT) IVD reagent :
    • ,
  • Inorganic phosphate (PO43-) IVD reagent :
    • ,
  • Urea IVD reagent :
    • ,
  • Total microprotein IVD kit nephelometry/turbidimetry :
    • ,
  • Total aspartate aminotransferase (AST) IVD reagent :
    • ,
  • Digoxin therapeutic drug monitoring IVD calibrator :
    • ,
  • Total cortisol IVD kit chemiluminescent immunoassay :
    • ,
  • Total cortisol IVD calibrator :
    • ,
  • Digoxin therapeutic drug monitoring IVD kit chemiluminescent assay :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD calibrator :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD control :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit chemiluminescent immunoassay :
    • ,
  • Multiple thyroid antibody IVD calibrator :
    • ,
  • Multiple thyroid antibody IVD control :
    • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit chemiluminescent immunoassay :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
    • ,
  • Creatinekinasemyocardialisoenzyme (CKMB) IVD kit chemiluminescent immunoassay :
    • ,
  • Cancer antigen 125 (CA125) IVD calibrator :
    • ,
  • Cancer antigen 125 (CA125) IVD control :
    • ,
  • Cancer antigen 125 (CA125) IVD kit chemiluminescent immunoassay :
    • ,
  • Myoglobin IVD calibrator :
    • ,
  • Myoglobin IVD control :
    • ,
  • Myoglobin IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroglobulin antibody IVD calibrator :
    • ,
  • Thyroglobulin antibody IVD control :
    • ,
  • Thyroglobulin antibody IVD kit chemiluminescent immunoassay :
    • ,
  • Thyroid uptake (T-uptake) IVD calibrator :
    • ,
  • Thyroid uptake (T-uptake) IVD control :
    • ,
  • Thyroid uptake (T-uptake) IVD kit chemiluminescent immunoassay :
    • ,
  • Total cholesterol lipid IVD reagent :
    • ,
  • Total protein IVD reagent :
    • ,
  • Triglyceride IVD reagent :
    • ,
  • Lipoprotein lipase IVD kit enzyme spectrophotometry :
    • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
    • ,
  • Conjugated (direct) bilirubin IVD reagent :
    • ,
  • Total acid phosphatase (TAP) IVD reagent :
    • ,
  • Haptoglobin IVD reagent :
    • ,
  • Apolipoprotein A-I (Apo A1) IVD reagent :
    • ,
  • Apolipoprotein B (Apo B) IVD reagent :
    • ,
  • Complement components C3/C3c IVD reagent :
    • ,
  • Complement components C4/C4c IVD reagent :
    • ,
  • Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetry :
    • ,
  • Immunoglobulin G subclass (IgG subclass) IVD kit nephelometry/turbidimetry :
    • ,
  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD calibrator :
    • ,
  • Cyclosporin A/cyclosporinetherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Phenobarbital IVD calibrator :
    • ,
  • Phenobarbitaltherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Phenytoin therapeutic drug monitoring IVD calibrator :
    • ,
  • Phenytoin therapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • Valproic acid therapeutic drug monitoring IVD calibrator :
    • ,
  • Valproicacidtherapeutic drug monitoring IVD kit chemiluminescent immunoassay :
    • ,
  • C-peptide IVD calibrator :
Abbott Laboratories1915 Hurd Drive LC/8

Texas
Irving 75038

United States

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202220388
  • Multiple clinical chemistry analyser IVD laboratory automated :
    • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
    • ,
  • Chemiluminescent immunoassay analyser IVD automated :
    • ,
  • Chemiluminescent immunoassay analyser IVD automated :
    • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
Abbott Medical Costa Rica LtdaEdificio #44 Calle 0 Ave. 2 Zona Franca

El Coyol Alajuela
N/A

Costa Rica

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
02/16/202223057
  • Cardiac mapping system reference patch :
    • ,
  • Cardiac mapping system reference patch :
Abbott Medical UK LimitedElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ

United Kingdom





11/13/202010922
  • Cardiac defect occluder :
Abbott Medical5050 Nathan Lane North

Plymouth
Minnesota 55442

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
01/15/202111588
  • Non-neurovascular embolization plug metallic :
    • ,
  • Cardiac sizing catheter :
    • ,
  • Cardiac occluder delivery kit :
    • ,
  • Atrial septal defect sizing plate :
    • ,
  • Cardiac mapping catheter percutaneous single-use :
    • ,
  • Cardiac defect occluder :
    • ,
  • Cardiac transseptal access set :
    • ,
  • Cardiac/peripheral vascular guidewire single-use :
    • ,
  • Cardiovascular catheter sheath :
    • ,
  • Catheter-tip transducer pressure :
    • ,
  • Electrical-only medical device connection cable reusable :
    • ,
  • Electrosurgical return electrode single-use :
    • ,
  • Percutaneous radio-frequency ablation probe denervation monopolar single-use :
    • ,
  • Percutaneous radio-frequency ablation system generator :
    • ,
  • Percutaneous radio-frequency ablation system probe cannula single-use :
    • ,
  • Vascular catheter introduction set nonimplantable :
    • ,
  • Vascular catheter introduction set nonimplantable :
    • ,
  • Vascular dilator single-use :
    • ,
  • Cardiac radio-frequency ablation system catheter :
    • ,
  • Cardiac radio-frequency ablation system catheter : Cardiac radio-frequency ablation system catheter Conformity Assessment Certificate Expired
    • ,
  • Electrical-only medical device connection cable reusable :
    • ,
  • Frame/rail/pole device holder :
Abbott Medical177 County Road B East

St. Paul
Minnesota 55117

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
02/18/202112227
  • Mitral transcatheter heart valve bioprosthesis :
    • ,
  • Self-expandable heart valve bioprosthesis collapsing tool single-use :
    • ,
  • Pressure monitor calibration weight :
    • ,
  • Pressure monitor calibration weight :
    • ,
  • Cardiovascular implant implantation tool base :
    • ,
  • Cardiac defect occluder :
    • ,
  • Cardiac occluder delivery kit :
Abbott Medical6901 Preston Road

Plano
Texas 75024

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
03/12/202112631
  • Deep brain electrical stimulation system :
    • ,
  • Neural-tissue electrical stimulation lead adaptor :
    • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead wired connection :
    • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension :
    • ,
  • Spinal procedural guidewire :
    • ,
  • Electrical-only medical device connection cable single-use :
    • ,
  • Central nervous system electrical stimulation system lead stylet :
    • ,
  • Epidural needle non-threaded :
    • ,
  • Cable/lead holder :
    • ,
  • Tendon/ligament tunneller :
    • ,
  • Neurosurgical procedure kit non-medicated single-use :
    • ,
  • Craniofacial fixation plate non-bioabsorbable :
    • ,
  • Active implantable device control magnet :
    • ,
  • Pin-indexed adaptor reusable :
    • ,
  • Implantable spinal cord electrical stimulation system programmer :
    • ,
  • Medical bag :
    • ,
  • Secondary battery :
    • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator implantable :
    • ,
  • Multiple active implantable device programmer :
    • ,
  • Noninvasive device battery charger :
    • ,
  • Multiple active implantable device programmer :
Abbott Medical3200 Lakeside Drive

Santa Clara
California 95054

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
03/28/202112987
  • Drug-eluting coronary artery stent non-bioabsorbable-polymer-coated :
    • ,
  • Peripheral vascular guidewire manual :
    • ,
  • Drug-eluting coronary artery stent non-bioabsorbable-polymer-coated :
    • ,
  • Cardiac/peripheral vascular guidewire single-use :
    • ,
  • Cardiac/peripheral vascular guidewire single-use :
Abbott Medical4 Robbins Road

Westford
Massachusetts 01886

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
04/14/202113383
  • Coronary optical coherence tomography system catheter :
    • ,
  • Coronary optical coherence tomography system :
    • ,
  • Cardiac catheterization laboratory computer :
    • ,
  • Coronary optical coherence tomography system catheter :
    • ,
  • Coronary optical coherence tomography system catheter :
Abbott Medical6035 Stoneridge Drive

PleaSANTON
California 94588

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
03/16/202223674
  • Electrical-only medical device connection cable reusable :
    • ,
  • Medical monitor/light mount :
    • ,
  • Circulatory assist system application software :
Abbott Molecular Inc.1350 E. Touhy Ave

Des Plaines IL
Illinois 60018

United States

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202213024
  • Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Hepatitis C virus nucleic acid IVD control :
    • ,
  • Hepatitis C virus nucleic acid IVD calibrator :
    • ,
  • HIV1 nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • HIV1 nucleic acid IVD control :
    • ,
  • HIV1 nucleic acid IVD calibrator :
    • ,
  • Nucleic acid sequencing reagent kit IVD :
    • ,
  • Hepatitis C virus genotyping IVD kit nucleic acid technique (NAT) :
    • ,
  • Hepatitis C virus genotyping IVD control :
    • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD control :
    • ,
  • Multiple congenital aneuploidy screening IVD control :
    • ,
  • Multiple congenital aneuploidy screening IVD probe :
    • ,
  • Cytomegalovirus (CMV) nucleic acid IVD calibrator :
    • ,
  • Cytomegalovirus (CMV) nucleic acid IVD control :
    • ,
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple congenital aneuploidy screening IVD probe :
    • ,
  • Tissue processor IVD automated :
    • ,
  • C-erbB2/Her2/neu oncoprotein IVD control :
    • ,
  • T-cell acute lymphoblastic leukaemia (T-ALL) genetic mutation IVD probe :
    • ,
  • Acute promyelocytic leukaemia (APL) genetic mutation IVD probe :
    • ,
  • B-cell malignancy IVD kit nucleic acid technique (NAT) :
    • ,
  • Nucleic acid hybridization detection IVD kit :
    • ,
  • Philadelphia chromosome/BCR-ABL mRNA expression IVD kit nucleic acid technique (NAT) :
    • ,
  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD probe :
    • ,
  • Idiopathic hypereosinophilic syndrome/chronic eosinophilic leukaemia IVD probe :
    • ,
  • Prader-Willi syndrome IVD probe :
    • ,
  • William-Beuren syndrome IVD probe :
    • ,
  • Cancer/tumour-associated aneuploidy IVD probe :
    • ,
  • Multiple myeloma genetic mutation IVD probe :
    • ,
  • Oligodendroglioma loss of heterozygosity (LOH) IVD probe :
    • ,
  • Bladder tumour-associated mutation IVD probe :
    • ,
  • Bladder tumour-associated mutation IVD control :
    • ,
  • Nucleic acid extraction/isolation kit IVD :
    • ,
  • General specimen container IVD no additive/medium :
    • ,
  • Nucleic acid hybridization detection IVD probe :
    • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • DAPI solution IVD :
    • ,
  • PCR instrument calibrator kit IVD :
    • ,
  • Cyclin D1 genetic mutation IVD probe :
    • ,
  • Phosphatase and tensin homolog (PTEN) gene IVD probe :
    • ,
  • Myelodysplastic syndrome (MDS) IVD probe :
    • ,
  • SRY gene sex-determination IVD probe :
    • ,
  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD control :
    • ,
  • Molecular grade lysis reagent IVD :
    • ,
  • Assay container IVD single-use :
    • ,
  • Laboratory instrument/analyser application software IVD :
    • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
    • ,
  • Molecular grade buffered sample diluent IVD :
    • ,
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD control :
    • ,
  • Cytology specimen container IVD transport buffer :
    • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD control :
    • ,
  • Multiple respiratory virus nucleic acid IVD control :
    • ,
  • Molecular grade alcohol IVD :
    • ,
  • Molecular grade procedure oil IVD :
    • ,
  • C-erbB2/Her2/neu oncoprotein IVD reagent :
    • ,
  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD probe :
    • ,
  • Philadelphia chromosome/BCR-ABL transcript IVD probe :
    • ,
  • DiGeorge syndrome IVD probe :
    • ,
  • B-cell malignancy IVD reagent :
    • ,
  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD probe :
    • ,
  • Acute myeloid leukaemia (AML) genetic mutation IVD probe :
    • ,
  • ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
    • ,
  • Nucleic acid hybridization detection IVD reagent :
    • ,
  • Laboratory waste receptacle IVD :
    • ,
  • Nucleic acid sample preparation instrument IVD automated :
    • ,
  • SARS-CoV-2 nucleic acid IVD control :
    • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD calibrator :
    • ,
  • Instrument/analyser test tube rack holder IVD :
    • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) : Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate Expired
    • ,
  • Hepatitis B virus nucleic acid IVD control : Hepatitis B virus nucleic acid IVD control Conformity Assessment Certificate Expired
    • ,
  • Hepatitis B virus nucleic acid IVD calibrator : Hepatitis B virus nucleic acid IVD calibrator Conformity Assessment Certificate Expired
Abbott Point of Care400 College Road East

Princeton
New Jersey 08540

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/31/202222502
  • Troponin I IVD reagent :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD reagent :
    • ,
  • Troponin I IVD control :
    • ,
  • Prothrombin time (PT) IVD reagent :
    • ,
  • Multiple traumatic brain injury marker IVD kit enzyme immunoassay (EIA) rapid :
    • ,
  • Multiple traumatic brain injury marker IVD control :
    • ,
  • Prothrombin time (PT) IVD control :
    • ,
  • Multichannel clinical chemistry analyser IVD point-of-care battery-powered :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
    • ,
  • Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD control :
    • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD control :
    • ,
  • Activated clotting time (ACT) IVD control :
    • ,
  • Activated clotting time (ACT) IVD kit clotting :
    • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD reagent :
    • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD reagent :
    • ,
  • Creatinine/ammonium electrode IVD :
    • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent :
Abbott Rapid Diagnostics Jena GmbHOrlaweg 1

Jena
Thuringia 07743

Germany

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
03/15/202112662
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • Clinical laboratory analyser/instrument control unit IVD :
    • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
    • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
    • ,
  • CD4 cell marker IVD kit fluorescent immunoassay rapid :
    • ,
  • SARS-CoV-2 antigen IVD control :
Abbott S.r.IViale Giorgio Ribotta 9 00144

Roma
00144

Italy

Abbott Laboratories LimitedUK Responsible PersonAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE
UK Responsible Person
England United Kingdom
danielle.angelino@abbott.com		04/28/202220389
  • Laboratory instrument/analyser application software IVD :
Abbott Toxicology Ltd21 Blacklands Way Abingdon Business Park

Abingdon
Oxfordshire OX14 1DY

United Kingdom





12/10/20199407
  • Amphetamine-specific IVD kit rapid ICT clinical :
    • ,
  • Barbiturate IVD kit rapid ICT clinical :
    • ,
  • Benzodiazepine group IVD kit rapid ICT clinical :
    • ,
  • Cannabinoid IVD kit rapid ICT clinical :
    • ,
  • Cocaine/cocaine metabolite IVD kit rapid ICT clinical :
    • ,
  • Methadone IVD kit rapid ICT clinical :
    • ,
  • Opiate/opiate metabolite IVD kit rapid ICT clinical :
    • ,
  • Phencyclidine (PCP) IVD kit rapid ICT clinical :
    • ,
  • Tricyclic antidepressant IVD kit rapid ICT clinical :
    • ,
  • Buprenorphine IVD kit enzyme immunoassay (EIA) :
    • ,
  • Amphetamine/methamphetamine group IVD kit rapid ICT clinical :
    • ,
  • Methamphetamine-specific IVD kit rapid ICT clinical :
    • ,
  • Morphine/morphine metabolite IVD kit rapid ICT clinical :
    • ,
  • Oxycodone IVD kit rapid ICT clinical :
    • ,
  • Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA) :
    • ,
  • 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA) :
    • ,
  • Propoxyphene/propoxyphene metabolite IVD kit rapid ICT clinical :
    • ,
  • Fentanyl IVD kit rapid ICT clinical :
    • ,
  • Tramadol IVD kit rapid ICT clinical :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Single-channel clinical chemistry analyser IVD point-of-care :
    • ,
  • Oral/upper respiratory tract specimen collection kit :
    • ,
  • Oral/upper respiratory tract specimen collection kit :
    • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
    • ,
  • Oral specimen collection swab :
    • ,
  • Dried blood spot collection kit IVD :
Abbott Vascular3200 Lakeside Drive

Santa Clara
California 95054

United States

Abbott Medical UK LimitedUK Responsible PersonElder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
UK Responsible Person
United Kingdom
02/16/202112177
  • Drug-eluting infrapopliteal artery stent non-bioabsorbable :
    • ,
  • Coronary angioplasty balloon catheter basic :
    • ,
  • Embolic protection filtering guidewire :
    • ,
  • Peripheral vascular guidewire manual :
    • ,
  • Bare-metal carotid artery stent :
    • ,
  • Vascular guide-catheter single-use :
    • ,
  • Bare-metal coronary artery stent :
    • ,
  • Cardiac/peripheral vascular guidewire single-use :
    • ,
  • Implantable vascular closure clip :
    • ,
  • Peripheral angioplasty balloon catheter basic :
    • ,
  • Heart valve clip :
    • ,
  • Peripheral artery stent bare-metal :
    • ,
  • Peripheral vascular guidewire manual :
    • ,
  • Catheter/overtube balloon inflator single-use :
    • ,
  • Torque manipulation device :
    • ,
  • Stopcock :
    • ,
  • Coronary artery guidewire extension :
    • ,
  • Peripheral vascular guidewire extension :
    • ,
  • Femoral vessel suture implantation set :
    • ,
  • Drug-eluting coronary artery stent non-bioabsorbable-polymer-coated :
    • ,
  • Cardiovascular implant implantation tool base :
    • ,
  • Vascular guidewire introduction sleeve :
AbbVie Inc1 North Waukegan Road

North Chicago
Illinois 60064

United States

AbbVie LtdUK Responsible PersonAbbVie House Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire SL6 4UB
UK Responsible Person
United Kingdom
09/27/202117874
  • Jejunostomy tube :
    • ,
  • Gastrostomy tube :
    • ,
  • Nasoenteral tube :
    • ,
  • Enteral feeding noninvasive-component set :
    • ,
  • Enteral feeding noninvasive-component set :
    • ,
  • Enteral feeding noninvasive-component set :
    • ,
  • Enteral feeding noninvasive-component set :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
    • ,
  • Personal device holder reusable :
ABC Dental Laboratory LimitedThe Studio Condover Mews Condover

Shrewsbury
Shropshire SY5 7BG

United Kingdom





10/16/20144697
  • Dental bridge metal-ceramic :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Sliding dental precision attachment :
    • ,
  • Resilient dental precision attachment :
    • ,
  • Dental implant suprastructure temporary preformed reusable :
    • ,
  • Magnetic dental precision attachment :
    • ,
  • Fluoride gel tray :
    • ,
  • Dental implant x-ray template :
    • ,
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Bonded dental bridge :
    • ,
  • Bar dental precision attachment :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Bite registration rim :
    • ,
  • Bite registration rim wax :
    • ,
  • Dental base plate :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Mouthguard single-use :
    • ,
  • Teeth whitening tray :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Resin dental inlay :
    • ,
  • Dental prosthesis veneer resin :
    • ,
  • 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 :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Gold dental inlay :
    • ,
  • Dental veneer professional :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental implant suprastructure permanent preformed :
    • ,
  • Dental implant suprastructure temporary preformed single-use :
    • ,
  • Overdenture :
    • ,
  • Orthodontic clasp metal custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Denture clasp metal custom-made :
ABC OPTICAL LTDSummers Opticians 407 Durham Road

Gateshead
NE9 5AN

United Kingdom





04/05/20198409
  • Prescription spectacles :
ABC SolutionsABC Solutions SRL Via Industria

63 30010 Camponogara VE
63 30010

Italy

Ambre-stone LtdUK Responsible PersonAmbre-Stone House (Rear Of Church View) Station Road
Langworth
Lincoln England
Lincolnshire LN3 5BD
UK Responsible Person
England United Kingdom
06/22/202225043
  • Assistive ergonomic chair manually-adjusted :
Abena A/SEgelund 35

Aabenraa
6200

Denmark

Abena UK LtdUK Responsible PersonSprint Point Dolomite Avenue Coventry Business Park

Coventry
CV5 6US
UK Responsible Person
United Kingdom
04/19/202221858
  • Infant nappy :
    • ,
  • Absorbent underpad non-antimicrobial single-use :
    • ,
  • Basic bed sheet reusable :
    • ,
  • Absorbent underpad non-antimicrobial single-use :
    • ,
  • Incontinence device suspender :
    • ,
  • Incontinence device suspender :
    • ,
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
    • ,
  • Vinyl examination/treatment glove powdered :
    • ,
  • Vinyl examination/treatment glove non-powdered :
    • ,
  • Vinyl examination/treatment glove non-powdered :
    • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
    • ,
  • Nitrile examination/treatment glove non-powdered antimicrobial :
    • ,
  • Incontinence pants single-use :
    • ,
  • Incontinence pants liner :
    • ,
  • Adult nappy :
    • ,
  • Medical networking interface unit :
    • ,
  • Emesis bag :
    • ,
  • Surgical/medical face mask single-use :
    • ,
  • Bib/apron adult single-use :
    • ,
  • Bib/apron adult single-use :
    • ,
  • Bib/apron adult reusable :
    • ,
  • Surgical coverall :
    • ,
  • Isolation gown single-use :
    • ,
  • Professional examination gown single-use :
    • ,
  • Scrub suit single-use :
    • ,
  • Scrub suit single-use :
    • ,
  • Surgical/examination garment kit :
    • ,
  • Surgical sleeve cover :
    • ,
  • Surgical cap single-use :
    • ,
  • Surgical patient underpants :
    • ,
  • Sealing-cuff scrub suit :
    • ,
  • Incontinence pants liner :
    • ,
  • Adult nappy :
    • ,
  • Incontinence pants single-use :
abergavenny dental laboratory13/14 nightingale terrace hanbury road
pontnewynydd
pontypool
torfaen np46pp

Wales United Kingdom





01/14/202111559
  • Custom-made mouthguard :
Abilia ABRåsundavägen 6

SOLNA
16967

Sweden

Abilia LtdUK Responsible PersonUnit 10 Buckingway Business Park Anderson Road
Swavesey
Cambridge
CB24 4AE
UK Responsible Person
England United Kingdom
02/24/202223221
  • Home seizure monitoring system :
    • ,
  • Bed/chair occupant movement sensor :
    • ,
  • Voice synthesizer/digitizer :
    • ,
  • Voice amplification system :
    • ,
  • Assistive clock/timepiece :
    • ,
  • Time-concept assistive training device :
    • ,
  • Assistive remote control :
    • ,
  • Assistive remote control :
    • ,
  • Assistive remote control :
    • ,
  • Assistive remote control :
    • ,
  • Assistive remote control :
    • ,
  • Assistive remote control :
    • ,
  • Assistive clock/timepiece :
    • ,
  • Time-concept assistive training device :
    • ,
  • Time-concept assistive training device :
    • ,
  • Assistive remote control :
Ability Matters Group Limited21 Nuffield Way

Abingdon
OX14 1RL

England United Kingdom

Meddev Solutions LimitedAuthorised Representative (Northern Ireland)River House Home Avenue

Newry
County Down BT34 2DL
Authorised Representative (Northern Ireland)
Northern Ireland United Kingdom
04/19/202220751
  • Ankle/foot orthosis :
    • ,
  • Orthotic shoe custom-made :
    • ,
  • Foot orthosis :
Abingdon Health PlcSand Hutton

York
Yorkshire YO41 1LZ

England United Kingdom





08/21/202010468
  • Kappa/lambda light chain immunoglobulin IVD control :
    • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
    • ,
  • Kappa/lambda light chain immunoglobulin IVD kit rapid ICT clinical :
    • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
Abiomed Inc.22 Cherry Hill Drive

Danvers
Massachusetts 01923

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
06/22/202225057
  • Intracardiac circulatory assist axial-pump catheter :
    • ,
  • Intracardiac circulatory assist axial-pump catheter :
    • ,
  • Surgical implant template single-use :
Abiores Technology (Beijing) Co. Ltd.No.8 Central Road Doudian Town
Fangshan District
Beijing
102433

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/12/202224169
  • Glucose rapid test/blood pressure system analyser home-use :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT self-testing :
    • ,
  • Follicle stimulating hormone (FSH) IVD kit rapid ICT self-testing :
    • ,
  • Faecal occult blood IVD kit rapid ICT self-testing :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
ABISS (ANALYTIC BIOSURGICAL SOLUTIONS)14 Rue de la Télématique

Saint-Etienne
Loire 42000

France

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202213701
  • Female stress urinary incontinence surgical mesh-sling synthetic polymer :
Ablative Solutions Inc.301 Edgewater Place Suite 100

Wakefield
MA 01880 01880

United States

ICON (LR) LimitedUK Responsible PersonConcept House 6 Stoneycroft Rise
Chandlers Ford Eastleigh
Hampshire
SO53 3LD
UK Responsible Person
England United Kingdom
11/08/202119538
  • Peripheral vascular intervention infusion catheter :
Ablatus TherapeuticsAblatus Therapeutics 31 Braintree Business Park
Blackwell Drive Braintree
Essex
None/Outside U.S. CM7 2PU

United Kingdom





04/13/20229512
  • Electrosurgical return electrode single-use :
AbleNet Inc.2625 Patton Road

Roseville
MN 55113

United States

EUCEREP LTD UK Responsible Person7 Tibbets Close Meeting Lane

Alcester Warwickshire
B49 5QU
UK Responsible Person
England United Kingdom
04/09/202223395
  • Assistive speech generator :
    • ,
  • Assistive human interface device proximal control hand-operated :
    • ,
  • Assistive electronic switch :
Aboca S.p.A. Società AgricolaLoc. Aboca 20

Sansepolcro (AR)
52037

Italy

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202216009
  • Gastro-oesophageal mucosa barrier :
ABON Biopharm (Hangzhou) Co. Ltd.#198 12th Street East Hangzhou Economic & Technological Development Zone

Hangzhou
Zhejiang 310018

China

Unipath Limited (trading as Alere International)UK Responsible PersonClearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP
UK Responsible Person
England United Kingdom
04/19/202113506
  • Chlamydia trachomatis antigen IVD kit rapid ICT clinical :
    • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
Absolute Dental2 Aspen Close

Stevenage
Hertfordshire SG2 8SJ

United Kingdom





04/06/20223812
  • Dental Appliances/Prostheses :
Absorbest ABKlintvägen 1

Kisa
Östergötland 59039

Sweden

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202215841
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
    • ,
  • Surgical towel :
    • ,
  • Dry medical towel/wipe single-use :
Abtek Biologicals Ltd7 Muir Road

Liverpool
Merseyside L9 7AR

United Kingdom





11/19/20106835
  • Cefepime susceptibility testing disc IVD :
    • ,
  • Ceftazidime/clavulanic acid susceptibility testing disc IVD :
    • ,
  • Ceftazidime susceptibility testing disc IVD :
    • ,
  • Cefsulodin susceptibility testing disc IVD :
    • ,
  • Cefradine susceptibility testing disc IVD :
    • ,
  • Cefprozil susceptibility testing disc IVD :
    • ,
  • Cefpodoxime susceptibility testing disc IVD :
    • ,
  • Cefpirome susceptibility testing disc IVD :
    • ,
  • Cefoxitin susceptibility testing disc IVD :
    • ,
  • Cefadroxil susceptibility testing disc IVD :
    • ,
  • Cefotiam susceptibility testing disc IVD :
    • ,
  • Cefotaxime susceptibility testing disc IVD :
    • ,
  • Cefoperazone/sulbactam susceptibility testing disc IVD :
    • ,
  • Cefoperazone susceptibility testing disc IVD :
    • ,
  • Cefixime susceptibility testing disc IVD :
    • ,
  • Ceftibutem susceptibility testing disc IVD :
    • ,
  • Cefdinir susceptibility testing disc IVD :
    • ,
  • Cefazolin susceptibility testing disc IVD :
    • ,
  • Cefamandole susceptibility testing disc IVD :
    • ,
  • Daptomycin susceptibility testing disc IVD :
    • ,
  • Cefaclor susceptibility testing disc IVD :
    • ,
  • Doxycycline susceptibility testing disc IVD :
    • ,
  • Econazole susceptibility testing disc IVD :
    • ,
  • Enrofloxacin susceptibility testing disc IVD :
    • ,
  • Ertapenem susceptibility testing disc IVD :
    • ,
  • Erythromycin susceptibility testing disc IVD :
    • ,
  • Cefotaxime/clavulanic acid susceptibility testing disc IVD :
    • ,
  • Cefoxitin differentiation disc IVD :
    • ,
  • Colistin sulfate susceptibility testing disc IVD :
    • ,
  • 5-Fluorocytosine susceptibility testing disc IVD :
    • ,
  • Amoxycillin susceptibility testing disc IVD :
    • ,
  • Amoxycillin/clavulanic acid susceptibility testing disc IVD :
    • ,
  • Amphotericin B susceptibility testing disc IVD :
    • ,
  • Ampicillin susceptibility testing disc IVD :
    • ,
  • Ampicillin/sulbactam susceptibility testing disc IVD :
    • ,
  • Apramycin susceptibility testing disc IVD :
    • ,
  • Azithromycin susceptibility testing disc IVD :
    • ,
  • Azlocillin susceptibility testing disc IVD :
    • ,
  • Aztreonam susceptibility testing disc IVD :
    • ,
  • Bacitracin susceptibility testing disc IVD :
    • ,
  • Carbenicillin susceptibility testing disc IVD :
    • ,
  • Beta-lactamase differentiation disc/strip IVD :
    • ,
  • Cloxacillin susceptibility testing disc IVD :
    • ,
  • Clotrimazole susceptibility testing disc IVD :
    • ,
  • Clindamycin susceptibility testing disc IVD :
    • ,
  • Clarithromycin susceptibility testing disc IVD :
    • ,
  • Ciprofloxacin susceptibility testing disc IVD :
    • ,
  • Cinoxacin susceptibility testing disc IVD :
    • ,
  • Chloramphenicol susceptibility testing disc IVD :
    • ,
  • Cephalothin susceptibility testing disc IVD :
    • ,
  • Cephalexin susceptibility testing disc IVD :
    • ,
  • Cefuroxime sodium susceptibility testing disc IVD :
    • ,
  • Ceftriaxone susceptibility testing disc IVD :
    • ,
  • Ceftizoxime susceptibility testing disc IVD :
    • ,
  • Ceftiofur susceptibility testing disc IVD :
    • ,
  • Itraconazole susceptibility testing disc IVD :
    • ,
  • Meropenem susceptibility testing disc IVD :
    • ,
  • Mecillinam susceptibility testing disc IVD :
    • ,
  • Loracarbef susceptibility testing disc IVD :
    • ,
  • Lomefloxacin susceptibility testing disc IVD :
    • ,
  • Linezolid susceptibility testing disc IVD :
    • ,
  • Lincomycin susceptibility testing disc IVD :
    • ,
  • Levofloxacin susceptibility testing disc IVD :
    • ,
  • Fluconazole susceptibility testing disc IVD :
    • ,
  • Ketoconazole susceptibility testing disc IVD :
    • ,
  • Kanamycin susceptibility testing disc IVD :
    • ,
  • Florfenicol susceptibility testing disc IVD :
    • ,
  • Imipenem susceptibility testing disc IVD :
    • ,
  • Gentamicin susceptibility testing disc IVD :
    • ,
  • Gatifloxacin susceptibility testing disc IVD :
    • ,
  • Fusidic acid susceptibility testing disc IVD :
    • ,
  • Furazolidone susceptibility testing disc IVD :
    • ,
  • Framycetin susceptibility testing disc IVD :
    • ,
  • Fosfomycin susceptibility testing disc IVD :
    • ,
  • Flumequine susceptibility testing disc IVD :
    • ,
  • Flucloxacillin susceptibility testing disc IVD :
    • ,
  • Nalidixic acid susceptibility testing disc IVD :
    • ,
  • Nafcillin susceptibility testing disc IVD :
    • ,
  • Novobiocin susceptibility testing disc IVD :
    • ,
  • Norfloxacin susceptibility testing disc IVD :
    • ,
  • Nitroxolin susceptibility testing disc IVD :
    • ,
  • Nitrofurantoin susceptibility testing disc IVD :
    • ,
  • Netilmicin susceptibility testing disc IVD :
    • ,
  • Neomycin sulfate susceptibility testing disc IVD :
    • ,
  • Natamycin susceptibility testing disc IVD :
    • ,
  • Novobiocin differentiation disc IVD :
    • ,
  • Mupirocin susceptibility testing disc IVD :
    • ,
  • Moxifloxacin susceptibility testing disc IVD :
    • ,
  • Miconazole susceptibility testing disc IVD :
    • ,
  • Metronidazole susceptibility testing disc IVD :
    • ,
  • Methicillin susceptibility testing disc IVD :
    • ,
  • Minocycline susceptibility testing disc IVD :
    • ,
  • Nystatin susceptibility testing disc IVD :
    • ,
  • Ofloxacin susceptibility testing disc IVD :
    • ,
  • Oleandomycin susceptibility testing disc IVD :
    • ,
  • Sulphonamide differentiation disc IVD :
    • ,
  • Roxithromycin susceptibility testing disc IVD :
    • ,
  • Sisomicin susceptibility testing disc IVD :
    • ,
  • Sparfloxacin susceptibility testing disc IVD :
    • ,
  • Spectinomycin susceptibility testing disc IVD :
    • ,
  • Spiramycin susceptibility testing disc IVD :
    • ,
  • Streptomycin susceptibility testing disc IVD :
    • ,
  • Sulphafurazole susceptibility testing disc IVD :
    • ,
  • Sulphamethoxazole susceptibility testing disc IVD :
    • ,
  • Rifampicin susceptibility testing disc IVD :
    • ,
  • Teicoplanin susceptibility testing disc IVD :
    • ,
  • Temocillin susceptibility testing disc IVD :
    • ,
  • Tetracycline susceptibility testing disc IVD :
    • ,
  • Tilmicosin susceptibility testing disc IVD :
    • ,
  • Ticarcillin susceptibility testing disc IVD :
    • ,
  • Tigecycline susceptibility testing disc IVD :
    • ,
  • Tobramycin susceptibility testing disc IVD :
    • ,
  • Trimethoprim susceptibility testing disc IVD :
    • ,
  • Perfloxacin susceptibility testing disc IVD :
    • ,
  • Optochin/ethylhydrocupreine differentiation disc IVD :
    • ,
  • Pyrrolidonyl arylamidase (PYR) microbial reagent IVD :
    • ,
  • Oxidase production microbial reagent IVD :
    • ,
  • Papanicolaou eosin azure 50 (EA-50) solution IVD :
    • ,
  • Ticarcillin/clavulanic acid susceptibility testing disc IVD :
    • ,
  • Trimethoprim/sulphamethoxazole susceptibility testing disc IVD :
    • ,
  • Oxacillin susceptibility testing disc IVD :
    • ,
  • Oxolinic acid susceptibility testing disc IVD :
    • ,
  • Sodium polyanethol sulfonate (SPS) differentiation disc IVD :
    • ,
  • Penicillin G susceptibility testing disc IVD :
    • ,
  • Pipemidic acid susceptibility testing disc IVD :
    • ,
  • Piperacillin susceptibility testing disc IVD :
    • ,
  • Piperacillin/tazobactam susceptibility testing disc IVD :
    • ,
  • Polymixin B susceptibility testing disc IVD :
    • ,
  • Pristinamycin susceptibility testing disc IVD :
    • ,
  • Quinupristin/dalfopristin susceptibility testing disc IVD :
    • ,
  • X factor differentiation disc IVD :
    • ,
  • X/V factor differentiation disc IVD :
    • ,
  • V factor differentiation disc IVD :
    • ,
  • Urea differentiation disc IVD :
    • ,
  • Vibrio 0129 differentiation disc IVD :
    • ,
  • Vancomycin susceptibility testing disc IVD :
    • ,
  • Voriconazole susceptibility testing disc IVD :
    • ,
  • Bacitracin differentiation disc IVD :
    • ,
  • Cefotetan susceptibility testing disc IVD :
    • ,
  • Amikacin susceptibility testing disc IVD :
    • ,
  • Culture medium antimicrobial supplement IVD :
    • ,
  • Catalase production microbial reagent IVD :
    • ,
  • Papanicolaou orange G-6 (OG-6) solution IVD :
    • ,
  • Hippurate hydrolase microbial reagent IVD :
    • ,
  • Coagulase production microbial reagent IVD :
    • ,
  • Bile solubility microbial reagent IVD :
    • ,
  • ONPG (ortho-nitrophenyl-beta-galactoside) differentiation disc IVD :
    • ,
  • Oxytetracycline susceptibility testing disc IVD :
    • ,
  • Campylobacter species broth culture medium IVD :
    • ,
  • Butzler Campylobacter species agar culture medium IVD :
    • ,
  • Blaser-Wang Campylobacter species agar culture medium IVD :
    • ,
  • Brain heart infusion (BHI) broth culture medium IVD :
    • ,
  • Brain heart infusion (BHI) agar culture medium IVD :
    • ,
  • Bismuth sulphite Salmonella species agar culture medium IVD :
    • ,
  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD :
    • ,
  • BCYE Legionella species agar culture medium IVD :
    • ,
  • Anaerobic transport medium IVD :
    • ,
  • Alkaline peptone water broth culture medium IVD :
    • ,
  • Anaerobic agar culture medium IVD no blood :
    • ,
  • Urea broth culture medium IVD :
    • ,
  • Urea agar culture medium IVD :
    • ,
  • Tryptic soy blood culture broth IVD :
    • ,
  • Brain heart infusion (BHI) blood culture broth IVD :
    • ,
  • Thioglycollate blood culture broth IVD :
    • ,
  • CFC Pseudomonas species agar culture medium IVD :
    • ,
  • Carey-Blair transport medium IVD :
    • ,
  • Bromocresol purple (BCP) agar culture medium IVD :
    • ,
  • Brucella species agar culture medium IVD :
    • ,
  • Buffered peptone water Salmonella species broth culture medium IVD :
    • ,
  • TSI Enterobacteriaciae agar differential medium IVD :
    • ,
  • Todd-Hewitt Streptococcus species broth culture medium IVD :
    • ,
  • TCBS Vibrio species agar culture medium IVD :
    • ,
  • MacConkey agar culture medium IVD crystal violet :
    • ,
  • Malt extract broth culture medium IVD :
    • ,
  • Mannitol-salt Staphylococcus species agar culture medium IVD :
    • ,
  • Basic/simple nutrient agar culture medium IVD :
    • ,
  • Nutrient agar culture medium IVD :
    • ,
  • Nutrient broth culture medium IVD :
    • ,
  • Potato-dextrose fungal agar culture medium IVD :
    • ,
  • Selenite Salmonella species broth culture medium IVD :
    • ,
  • MacConkey agar culture medium IVD no crystal violet :
    • ,
  • XLD Enteric pathogen agar culture medium IVD :
    • ,
  • MRSA agar culture medium IVD selective antimicrobial :
    • ,
  • Lysine/iron Salmonella species agar differential medium IVD :
    • ,
  • Kligler-iron Enterobacteriaceae agar culture medium IVD :
    • ,
  • Listeria species agar culture medium IVD :
    • ,
  • Listeria species broth culture medium IVD :
    • ,
  • Thayer-Martin Neisseria species agar culture medium IVD :
    • ,
  • Sorbitol-MacConkey E. coli agar culture medium IVD :
    • ,
  • Cetrimide Pseudomonas aeruginosa agar culture medium IVD :
    • ,
  • CCDA Campylobacter species agar culture medium IVD :
    • ,
  • Bile esculin Enterococcus species agar culture medium IVD :
    • ,
  • Simmons-citrate Enterobacteriaceae agar culture medium IVD :
    • ,
  • Sabouraud dextrose fungal agar culture medium IVD :
    • ,
  • Salmonella/Shigella species agar culture medium IVD :
    • ,
  • Dnase Staphylococcus species agar culture medium IVD :
    • ,
  • Candida species agar culture medium IVD basic :
    • ,
  • CIN Yersinia species agar culture medium IVD :
    • ,
  • Clostridium species agar culture medium IVD basic :
    • ,
  • Columbia agar culture medium IVD 5% horse blood :
    • ,
  • Basic/simple nutrient broth culture medium IVD :
    • ,
  • Columbia agar culture medium IVD no blood :
    • ,
  • Differential/selective agar culture medium IVD :
    • ,
  • Cystine lactose electrolyte deficient (CLED) agar culture medium IVD :
    • ,
  • Dermatophyte agar culture medium IVD :
    • ,
  • Desoxycholate agar culture medium IVD :
Abtrace LimitedImperial House 8 Kean Street

LONDON
WC2B 4AS

England United Kingdom





09/30/202010648
  • Clinical management support software :
Acandis GmbHTheodor-Fahrner-Str. 6

Pforzheim
75177

Germany

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH
UK Responsible Person
England United Kingdom
04/19/202113537
  • Bare-metal intracranial vascular stent :
    • ,
  • Vascular microcatheter :
    • ,
  • Vascular guide-catheter single-use :
    • ,
  • Peripheral angioplasty balloon catheter basic :
    • ,
  • Thrombectomy wire-net :
    • ,
  • Bare-metal intracranial vascular stent :
Acare Medical Science Co. Ltd.No.8 Pingxi 10th Road Nanping Science and Technology Industrial Park Xiangzhou District

Zhuhai City
Guangdong 519060

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
06/21/202225018
  • Basic electric hospital bed :
Acarix A/SAcarix Ryvangs Allé 81-83

Hellerup
2900

Denmark

Acarix LTDUK Responsible PersonCarpenter Court 1 Maple Road

Bramhall
Stockport Cheshire SK7 2DH
UK Responsible Person
England United Kingdom
04/28/202224380
  • Phonocardiograph :
    • ,
  • Phonocardiograph :
Accel-Heal Technologies LimitedHever Business Centre The Old Station

Hever
Kent TN8 7ER

England United Kingdom

customerservices@accelheal.com





05/14/202114692
  • Injured-tissue electrical stimulation system :
Access Dental Lab LLC1530 Antioch Pike

Antioch
Tennessee 37013

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/30/202120564
  • Dental impression tray single-use :
    • ,
  • Silicone dental impression material :
    • ,
  • Dental cheek retractor home-use :
    • ,
  • Orthodontic retainer :
    • ,
  • Orthodontic progressive aligner :
    • ,
  • Silicone dental impression material :
Access Genetics LLC7400 Flying Cloud Drive Suite 150

Eden Prairie
Minnesota 55344

United States

EU-UK Authorised Representative LtdAuthorised Representative (Northern Ireland) UK Responsible PersonUnit 591 Moat House
54 Bloomfield Avenue
Belfast
BT5 5 AD
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
05/12/202224609
  • General specimen collection kit IVD clinical :
Access Point Technologies EP Inc.12560 Fletcher Lane #300

Rogers
Minnesota 55374

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/07/202119156
  • Electrical-only medical device connection cable reusable :
    • ,
  • Cardiac mapping catheter percutaneous single-use :
    • ,
  • Cardiac radio-frequency ablation system catheter :
Access UK LimitedThe Old School
Stratford St Mary
Colchester
CO7 6LZ

England United Kingdom
07803 118565
Victoria.mudd@theaccessgroup.com





04/09/20225882
  • Standalone Software :
    • ,
  • Clinical information system web-based application software :
Accora LimitedCharter House Barrington Road
Orwell
Cambridge
Cambridgeshire SG8 5QP

England United Kingdom





12/24/202121553
  • Electrical assistive bed :
    • ,
  • Electrical assistive bed :
    • ,
  • Electrical assistive bed :
    • ,
  • Electrical assistive bed :
    • ,
  • Electrical assistive bed :
    • ,
  • Assistive ergonomic chair electrically-adjusted :
    • ,
  • Reclining chair :
    • ,
  • Reclining chair :
    • ,
  • Foam-filled bed mattress overlay :
    • ,
  • Assistive ergonomic chair electrically-adjusted :
Accrington Surgical Instrument Supplies LtdUnit 6A Petre Court Petre Road Clayton Business Park Clayton Le Moors

Accrington
Lancashire BB5 5HY

United Kingdom





06/21/20124103
  • Syringes (Hypodermic/Oral/Irrigation) :
    • ,
  • Handheld Dental Mirrors And Accessories :
    • ,
  • Stethoscopes :
    • ,
  • Bandages (Eg Support/Tubular/Adhesive/Plaster Of Paris/Cast Liners/Resin) :
    • ,
  • Tubes (Oesophageal/Rectal) And Accessories :
    • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
    • ,
  • Pre-Operative Devices (Razor/Marker Pen) :
    • ,
  • Laryngoscopes/Otoscopes And Accessories :
    • ,
  • Urinary Catheters (Transient Use) And Accessories :
    • ,
  • Eye Speculums :
    • ,
  • Vaginal Speculums :
    • ,
  • Rectal Dilators And Lubricants :
    • ,
  • Dissecting Forceps :
    • ,
  • Nasal Speculum :
    • ,
  • Patella Hammers (Reflex Testing Devices) :
    • ,
  • Cannulae (Reusable) :
    • ,
  • Tongue And Cheek Retractors :
    • ,
  • Proctoscopes Anascopes And Accessories :
    • ,
  • Sphygmomanometers And Accessories :
    • ,
  • Enema and douche devices :
    • ,
  • Surgical Instrument Accessories :
    • ,
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
Accriva Diagnostics6260 Sequence Drive

San Diego
92121

United States

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202218720
  • Blood lancet single-use :
    • ,
  • Multiple blood gas analyte IVD reagent :
    • ,
  • Co-oximetry analyser IVD point-of-care :
    • ,
  • Multiple coagulation factor IVD control :
    • ,
  • Multiple coagulation factor IVD reagent :
    • ,
  • Activated partial thromboplastin time (APTT) IVD reagent :
    • ,
  • Prothrombin time (PT) IVD reagent :
    • ,
  • Activated clotting time (ACT) IVD reagent :
    • ,
  • Platelet aggregation study IVD reagent :
    • ,
  • Coagulation analyser IVD laboratory semi-automated :
    • ,
  • Coagulation analyser IVD point-of-care line-powered :
    • ,
  • Platelet aggregation analyser IVD semi-automated :
    • ,
  • Coagulation analyser IVD laboratory semi-automated :
    • ,
  • Coagulation analyser IVD point-of-care line-powered :
Accurate Dental LaboratoryAccurate Dental Laboratory 5 Castle Hill Court

Huntingdon
Cambridgeshire PE29 3TJ

England United Kingdom





01/05/202111369
  • Custom-made dental anatomy model :
Accurate Medical Therapeutics Ltd19 Eli Hurvitz Street

Rehovot
7608802

Israel

Guerbet Laboratories Ltd.UK Responsible Person435 Stratford Road

Shirley
Solihull B90 4AA
UK Responsible Person
England United Kingdom
04/22/202215835
  • Vascular microcatheter :
Accuray Incorporated1209 Deming Way

Madison
Wisconsin 53717

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/18/202118374
  • Linear accelerator system :
    • ,
  • Radiation therapy treatment planning workstation :
Accutron Inc./Crosstex International1733 West Parkside Lane

Phoenix
Arizona 85027

United States

Cantel (UK) LtdUK Responsible PersonCampfield Road Shoeburyness

Southend on Sea
Essex SS3 9BX
UK Responsible Person
United Kingdom
04/08/202113191
  • Oxygen/air/nitrous oxide breathing gas mixer :
    • ,
  • Anaesthesia face mask single-use :
    • ,
  • Anaesthesia breathing circuit reusable :
Accuvein Inc.3243 ROUTE 112 BUILDING 1
SUITE 2
Medford
New York 11763

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/07/202222702
  • Infrared-light vein locator :
    • ,
  • Mobile medical equipment stand non-powered :
    • ,
  • Mobile medical equipment stand electrically-powered :
Ace Dental Laboratory12 Middleton Park Avenue
GBR
LEEDS
West Yorkshire LS10 4HP

United Kingdom





03/19/20209715
  • 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 :
    • ,
  • 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 bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Preformed complete denture :
    • ,
  • Dental veneer professional :
    • ,
  • Orthodontic retainer :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Mouthguard reusable :
    • ,
  • Denture reliner soft home-use :
Ace Orthotics LtdSanatorium Road Canton

Cardiff
CF11 8DG

United Kingdom





08/21/20073097
  • Orthotic shoe non-customized :
    • ,
  • Orthotic shoe adapted :
    • ,
  • Orthotic insole custom-made :
    • ,
  • Orthotic insole prefabricated non-antimicrobial :
    • ,
  • Foot orthosis :
    • ,
  • Hallux valgus metatarsophalangeal orthosis :
    • ,
  • Ankle/foot orthosis :
    • ,
  • Calf/shin orthosis :
ACE Surgical Supply Company Inc.1034 Pearl Street

Brockton MA
02301

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
04/27/202113943
  • Orthodontic anchoring screw :
    • ,
  • Extra-gynaecological surgical mesh metal :
    • ,
  • Screw endosteal dental implant one-piece :
    • ,
  • Dental prosthesis/implant abutment screw :
    • ,
  • Dental implant abutment impression cap :
    • ,
  • Dental implant suprastructure aligner :
    • ,
  • Bone tap reusable :
    • ,
  • Surgical drill guide reusable :
    • ,
  • Skin-coring punch reusable :
    • ,
  • Fluted surgical drill bit single-use :
    • ,
  • General external orthopaedic fixation system implantation kit reusable :
    • ,
  • Dental implantation drilling template retention pin :
    • ,
  • Titanium dental bur :
    • ,
  • Screw endosteal dental implant one-piece :
    • ,
  • Carbide dental bur single-use :
    • ,
  • Steel dental bur single-use :
    • ,
  • Orthopaedic implant driver :
    • ,
  • Dental suction system cannula soft tip :
    • ,
  • Oxygen administration hood adult :
    • ,
  • General-purpose surgical sponge :
    • ,
  • Dental torque wrench :
    • ,
  • Dental osteotome :
    • ,
  • Maxillofacial bone wire/bar :
    • ,
  • General surgical procedure kit non-medicated reusable :
    • ,
  • Desk mount :
    • ,
  • General-purpose bowl reusable :
    • ,
  • Soft-tissue surgical hook reusable :
    • ,
  • Dental root separator :
    • ,
  • Dental irrigation/aspiration syringe :
    • ,
  • Dental explorer :
    • ,
  • Nasal speculum reusable :
    • ,
  • Fixture/appliance dental drill bit reusable :
    • ,
  • Hand-held surgical retractor reusable :
    • ,
  • Scalpel blade remover non-sterile :
    • ,
  • Dental precision attachment fitting/adjustment tool :
    • ,
  • Dental prosthesis/implant abutment screw analog single-use :
    • ,
  • Manual dental burnisher reusable :
    • ,
  • Mouth gag support reusable :
    • ,
  • Bone collection scraper :
    • ,
  • Surgical irrigation/aspiration cannula illuminating single-use :
    • ,
  • Dental guided surgery registration/navigation fiducial marker :
    • ,
  • General-purpose curette :
    • ,
  • Luer/non-ISO80369-standardized linear connector reusable :
    • ,
  • Screw endosteal dental implant one-piece :
    • ,
  • Dental implant system :
    • ,
  • Bone grafting cannula :
    • ,
  • Patient surgical drape single-use :
    • ,
  • Orthopaedic chisel blade :
    • ,
  • Surgical instrument/endoscope cleaning utensil reusable :
    • ,
  • Intravenous pressure infusor manual reusable :
    • ,
  • Suturing needle holder reusable :
    • ,
  • Scalpel handle reusable :
    • ,
  • Instrument tray reusable :
    • ,
  • Elbow immobilizer :
    • ,
  • Nasal chisel :
    • ,
  • Dental articulator :
    • ,
  • Medical ruler reusable :
    • ,
  • Stationary panoramic dental x-ray system analogue :
    • ,
  • Bone-angle protractor :
    • ,
  • Surgical drill guide reusable :
    • ,
  • General-purpose calliper metallic :
    • ,
  • Periodontal probe reusable :
    • ,
  • Gauze packer :
    • ,
  • Bone awl reusable :
    • ,
  • Dental rongeur :
    • ,
  • Rigid arthroscope reusable :
    • ,
  • Orthodontic pliers :
    • ,
  • Orthopaedic implant driver :
    • ,
  • Surgical mallet :
    • ,
  • Periodontal probe reusable :
    • ,
  • Dental surgical scissors :
    • ,
  • Dental dressing forceps reusable :
    • ,
  • Dental mirror reusable :
    • ,
  • Bone curette reusable :
    • ,
  • Manual bone mill :
    • ,
  • Tourniquet cuff reusable :
    • ,
  • Suction/irrigation tubing single-use :
    • ,
  • Dental elevator tooth/root :
    • ,
  • Dental implantation depth/angle gauge reusable :
ACEKARE7 rue MIREPORT

LORMONT Aquitaine
33310

France

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
12/29/202120966
  • Wheelchair electric-motor-driven propulsion system :
Aceonedent Korea Ind. Co103-606 Bucheon Techno-Park 22 Samjak-ro
Ojeong-Gu Bucheon si
Gyeonggi-do
14501

South Korea

Perfection Plus LtdUK Responsible PersonUnit 6 Westwood Court Brunel Road
Totton
Southampton
Hampshire SO40 3WX
UK Responsible Person
United Kingdom
06/04/202223973
  • Endodontic paper point :
    • ,
  • Natural gutta-percha :
ACIST Europe BVArgonstraat 3

Heerlen
6422 PH

Netherlands

Bracco UK LimitedUK Responsible PersonMagdalene Centre The Oxford Science Park

Oxford
OX4 4GA
UK Responsible Person
England United Kingdom
04/30/202114256
  • Contrast medium injection system syringe :
    • ,
  • Contrast medium injection system administration set :
    • ,
  • Contrast medium injection system hand controller kit :
    • ,
  • Cardiovascular ultrasound imaging system :
    • ,
  • Cardiac catheterization laboratory computer :
    • ,
  • Catheter-tip transducer pressure : Catheter-tip transducer pressure Conformity Assessment Certificate Expired
    • ,
  • Intravascular ultrasound imaging catheter single-use : Intravascular ultrasound imaging catheter single-use Conformity Assessment Certificate Expired
    • ,
  • Angiography contrast medium injection system line-powered mobile : Angiography contrast medium injection system line-powered mobile Conformity Assessment Certificate Expired
Ackermann Instrumente GmbHEisenbahnstr. 65-67

Rietheim-Weilheim
Baden-Württemberg 78604

Germany

MEDAGENT INTERNATIONAL UK LIMITEDUK Responsible Person2 St Andrews Place

Lewes
East Sussex BN7 1UP
UK Responsible Person
England United Kingdom
04/15/202215864
  • Rigid optical laparoscope :
    • ,
  • Rigid nephroscope :
    • ,
  • Rigid cystoscope :
    • ,
  • Rigid arthroscope reusable :
    • ,
  • Ligation clip metallic :
    • ,
  • Stone/foreign-body extraction set :
    • ,
  • Arthroscopic shaver system electrically-powered :
    • ,
  • Rigid optical hysteroscope :
    • ,
  • Rigid endoscope working guide :
    • ,
  • Rigid ureterorenoscope :
    • ,
  • Laparoscopic access cannula reusable :
    • ,
  • Arthroscopic shaver system blade reusable :
    • ,
  • Arthroscopic shaver system blade single-use :
    • ,
  • Spring-loaded pneumoperitoneum needle reusable :
    • ,
  • Endoscopic electrosurgical handpiece/electrode monopolar single-use :
    • ,
  • Endoscopic electrosurgical electrode monopolar reusable :
    • ,
  • Intrauterine cannula reusable :
    • ,
  • Surgical suction pump :
    • ,
  • Suction/irrigation tubing reusable :
    • ,
  • Endoscopic electrosurgical handpiece/electrode bipolar reusable :
    • ,
  • Rigid endoscopic biopsy forceps reusable :
    • ,
  • Endoscopic electrosurgical handpiece/electrode monopolar reusable :
    • ,
  • General-purpose syringe reusable :
    • ,
  • Nasal speculum reusable :
    • ,
  • General-purpose surgical scissors reusable :
    • ,
  • Fixed-diameter cervical dilator reusable :
    • ,
  • Vaginal speculum reusable :
    • ,
  • Soft-tissue surgical hook reusable :
    • ,
  • General-purpose surgical spatula :
    • ,
  • Orthopaedic chisel :
    • ,
  • Orthopaedic osteotome :
    • ,
  • Surgical bulldog clamp reusable :
    • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
    • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
    • ,
  • Hand-held surgical retractor reusable :
    • ,
  • Manual surgical saw rigid :
    • ,
  • Self-retaining ear speculum :
    • ,
  • Mouth gag adjustable reusable :
    • ,
  • Bone lever/elevator reusable :
    • ,
  • Surgical mallet :
    • ,
  • Towel clamp reusable :
    • ,
  • Vessel approximator :
    • ,
  • Rectal speculum :
    • ,
  • Vein stripper reusable :
    • ,
  • General-purpose absorbent tip applicator/swab reusable :
    • ,
  • Tonsil snare :
    • ,
  • Cannula clamp :
    • ,
  • Common bile duct dilator :
    • ,
  • Surgical snare wire :
    • ,
  • Male intraurethral catheter/valve :
    • ,
  • Maxillofacial bone separator :
    • ,
  • Uterine probe :
    • ,
  • Ophthalmic soft-tissue manipulation forceps probe-like reusable :
    • ,
  • Gastrointestinal needle catheter :
    • ,
  • Urethral catheterization support kit urinary drainage :
    • ,
  • General physical examination set :
    • ,
  • Pinwheel aesthesiometer :
    • ,
  • Direct ophthalmoscope :
    • ,
  • Tracheal surgery dilator reusable :
    • ,
  • Finger protector reusable :
    • ,
  • Medical ruler reusable :
    • ,
  • Bone awl reusable :
    • ,
  • Dermatome handle :
    • ,
  • Vascular dilator reusable :
    • ,
  • Enucleation scissors :
    • ,
  • Scalp clip forceps :
    • ,
  • Tracheostomy kit reusable :
    • ,
  • Female wearable urinal reusable :
    • ,
  • General skin wound clip :
    • ,
  • Dental explorer :
    • ,
  • Bone marker :
    • ,
  • Tendon stripper :
    • ,
  • Skin-coring punch reusable :
    • ,
  • Proctoscope reusable :
    • ,
  • Common bile duct probe :
    • ,
  • Wire/ligature passer reusable :
    • ,
  • Otoscope direct :
    • ,
  • Dental elevator tooth/root :
    • ,
  • Dissection kit :
    • ,
  • Orthopaedic prosthesis implantation instrument reusable :
    • ,
  • Open-surgery ligation clip applier :
    • ,
  • Rigid intubation laryngoscope reusable :
    • ,
  • Corneal trephine manual instrument :
    • ,
  • Bone file/rasp manual reusable :
    • ,
  • Laparoscopic trocar blade reusable :
    • ,
  • Endoscopic video image processing/light source system :
    • ,
  • Rigid endoscopic tissue manipulation forceps reusable :
    • ,
  • Endoscopic surgical ligation clip applier reusable :
    • ,
  • Suture knot pusher reusable :
    • ,
  • Surgical instrument clip :
    • ,
  • General-purpose endoscopic needle reusable :
    • ,
  • Externally-anchored laparoscopic retractor :
    • ,
  • Lacrimal probe reusable :
    • ,
  • Flexible endoscopic biopsy forceps reusable :
    • ,
  • Otoscope endoscopic :
    • ,
  • Ear knife :
    • ,
  • Bladder evacuator reusable :
    • ,
  • Manual surgical rotary handpiece reusable :
    • ,
  • Laparoscopic access cannula reusable :
    • ,
  • Surgical retractor/retraction system blade reusable :
    • ,
  • Fistula probe :
    • ,
  • Suturing unit reusable :
    • ,
  • Suturing needle holder reusable :
    • ,
  • Bone-coring punch reusable :
    • ,
  • Bone curette reusable :
    • ,
  • Scalpel reusable :
    • ,
  • ENT elevator :
    • ,
  • Flexible fibreoptic ureterorenoscope :
    • ,
  • Urethral dilator reusable :
    • ,
  • Urethral dilator reusable :
    • ,
  • Suction/irrigation tubing reusable :
    • ,
  • Suction/irrigation tubing reusable :
    • ,
  • Manual dental scaler reusable :
    • ,
  • General-purpose bowl reusable :
    • ,
  • Tuning fork :
    • ,
  • Ophthalmic tonometer manual :
    • ,
  • Leg procedure positioner :
    • ,
  • Foot-switch pneumatic :
    • ,
  • Foot-switch electrical :
    • ,
  • Electrical-only medical device connection cable reusable :
    • ,
  • Manual goniometer :
    • ,
  • Percussion hammer manual :
    • ,
  • Mechanical stethoscope :
    • ,
  • General-purpose light source :
    • ,
  • Laryngeal mirror reusable :
    • ,
  • Back/leg/chest dynamometer mechanical :
    • ,
  • Cast cutter line-powered :
    • ,
  • Endoscopic light source unit line-powered :
    • ,
  • Endoscopic video image display monitor :
    • ,
  • Endoscope video camera :
    • ,
  • Surgical instrument/endoscope cleaning utensil reusable :
    • ,
  • Sterilization/disinfection container reusable :
    • ,
  • Open-surgery biopsy forceps reusable :
ACL GmbHApelsteinallee 5

Markkleeberg
04416

Germany

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
02/01/202221942
  • Image display monitor colour :
ACME COMMERCIAL WAYS (PVT) LTDP.O. Box # 1092

sialkot
51310

Pakistan

HDJ Ltd UK Responsible Person13 Churchfields Avenue

Feltham
England Tw135pb
UK Responsible Person
England United Kingdom
03/29/202112990
  • Tongue depressor surgical :
    • ,
  • Orthopaedic joint/limb rongeur :
    • ,
  • Bone cutting forceps :
    • ,
  • Dental dressing forceps reusable :
    • ,
  • Tooth extraction forceps :
    • ,
  • Nail extraction forceps :
    • ,
  • Wire holding/twisting forceps :
    • ,
  • Suturing needle holder reusable :
    • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
    • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
    • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
    • ,
  • Airway tube forceps reusable :
    • ,
  • Dressing/utility forceps scissors-like reusable :
    • ,
  • Obstetrical forceps reusable :
    • ,
  • Bone holding forceps :
    • ,
  • Hand-held surgical retractor reusable :
    • ,
  • Self-retaining surgical retractor reusable :
    • ,
  • General-purpose surgical scissors reusable :
    • ,
  • Umbilical cord scissors reusable :
    • ,
  • Bandage scissors reusable :
    • ,
  • Scalpel reusable :
    • ,
  • Scalpel handle reusable :
    • ,
  • Orthopaedic osteotome :
    • ,
  • Rectal dilator reusable :
    • ,
  • Towel clamp reusable :
    • ,
  • Open-surgery ligation clip applier :
    • ,
  • Periosteal elevator reusable :
    • ,
  • Bone curette reusable :
    • ,
  • Surgical gouge :
    • ,
  • Soft-tissue surgical hook reusable :
    • ,
  • Vaginal speculum reusable :
    • ,
  • Bone file/rasp manual reusable :
    • ,
  • Surgical mallet :
    • ,
  • Percussion hammer manual :
    • ,
  • Ear canal irrigation syringe :
    • ,
  • Eyelid speculum reusable :
    • ,
  • Dental spatula reusable :
    • ,
  • Nasal speculum reusable :
    • ,
  • Dental elevator tooth/root :
    • ,
  • Dental impression tray reusable :
    • ,
  • Dental explorer :
    • ,
  • Manual dental scaler reusable :
    • ,
  • Rectal probe :
    • ,
  • Endaural surgical curette reusable :
    • ,
  • General surgery wound probe/packer :
    • ,
  • Tonsil dissector reusable :
    • ,
  • Dental amalgam carrier :
    • ,
  • Cast cutting shears :
    • ,
  • Rib spreader reusable :
    • ,
  • Wire cutter :
    • ,
  • Wire holding/twisting pliers :
    • ,
  • Sterilization/disinfection container reusable :
    • ,
  • Instrument tray reusable :
    • ,
  • Laryngoscope handle reusable :
    • ,
  • Laryngoscope blade reusable :
    • ,
  • Dental mirror reusable :
    • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
    • ,
  • Fistula probe :
    • ,
  • Manual surgical saw rigid :
    • ,
  • Rubber dam clamp forceps :
Acme Dental Laboratories Ltd136 Waterloo Road Burslem

Stoke-On-Trent
Staffordshire ST6 3HB

United Kingdom





04/08/20225127
  • Dental Appliances/Prostheses :
ACON Biotech (Hangzhou) Co LtNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202211766
  • Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automated :
    • ,
  • Fluorescent immunoassay analyser IVD point-of-care line-powered :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT self-testing :
    • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
    • ,
  • Multiple Orthopoxvirus nucleic acid IVD kit nucleic acid technique (NAT) :
    • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
Acon Laboratories Inc.5850 Oberlin Drive #340

San Diego CA
92121

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
04/07/202113082
  • Fluorescent immunoassay analyser IVD point-of-care line-powered :
    • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automated :
    • ,
  • Blood lancet single-use :
    • ,
  • Manual blood lancing device reusable :
    • ,
  • Triglyceride IVD kit enzyme spectrophotometry :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD control :
    • ,
  • Total cholesterol lipid IVD control :
    • ,
  • Triglyceride IVD control :
    • ,
  • Total cholesterol lipid IVD kit enzyme spectrophotometry :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometry :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD control :
    • ,
  • Total cholesterol lipid IVD control :
    • ,
  • Triglyceride IVD control :
    • ,
  • Total cholesterol lipid IVD kit enzyme spectrophotometry :
    • ,
  • High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometry :
    • ,
  • Triglyceride IVD kit enzyme spectrophotometry :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
    • ,
  • Glucose IVD control :
    • ,
  • Glucose IVD control :
    • ,
  • Uric acid IVD control :
    • ,
  • Uric acid IVD control :
    • ,
  • Glucose/ketone/lipid profile IVD control :
    • ,
  • Glucose/ketone/lipid profile IVD control :
    • ,
  • Uric acid monitoring system IVD home-use :
    • ,
  • Uric acid monitoring system IVD home-use :
    • ,
  • Glucose monitoring system IVD home-use :
    • ,
  • Glucose monitoring system IVD home-use :
    • ,
  • Glucose/ketone monitoring system IVD home-use :
    • ,
  • Glucose/ketone monitoring system IVD home-use :
    • ,
  • Glucose/ketone monitoring system IVD home-use :
    • ,
  • Total haemoglobin (totHb) IVD control :
    • ,
  • Haemoglobin detection IVD control :
    • ,
  • Haemoglobin/hematocrit IVD kit electrometry :
    • ,
  • Haemoglobin/hematocrit analyser IVD :
    • ,
  • Coagulation factor II (prothrombin) IVD control :
    • ,
  • Coagulation factor II (prothrombin) IVD kit chromogenic :
    • ,
  • Coagulation factor II (prothrombin) IVD control :
    • ,
  • Coagulation factor II (prothrombin) IVD kit chromogenic :
    • ,
  • Multiple urine analyte IVD kit colorimetric dipstick rapid :
    • ,
  • Urine blood IVD kit colorimetric rapid :
    • ,
  • Urine bilirubin IVD kit colorimetric dipstick rapid :
    • ,
  • Urine creatinine IVD kit colorimetric dipstick rapid :
    • ,
  • Urine glucose IVD kit colorimetric dipstick rapid :
    • ,
  • Urine ketone IVD kit colorimetric dipstick rapid :
    • ,
  • Urine leukocyte IVD kit colorimetric dipstick rapid :
    • ,
  • Urine nitrite IVD kit colorimetric dipstick rapid :
    • ,
  • Urine pH IVD kit colorimetric dipstick rapid :
    • ,
  • Urine protein IVD kit colorimetric dipstick rapid :
    • ,
  • Urine specific gravity IVD kit colorimetric dipstick rapid :
    • ,
  • Urine urobilinogen IVD kit colorimetric dipstick rapid :
    • ,
  • Urine albumin IVD kit colorimetric dipstick rapid :
    • ,
  • Multiple urine analyte IVD kit colorimetric dipstick rapid :
    • ,
  • Urine blood IVD kit colorimetric rapid :
    • ,
  • Urine bilirubin IVD kit colorimetric dipstick rapid :
    • ,
  • Urine glucose IVD kit colorimetric dipstick rapid :
    • ,
  • Urine ketone IVD kit colorimetric dipstick rapid :
    • ,
  • Urine leukocyte IVD kit colorimetric dipstick rapid :
    • ,
  • Urine nitrite IVD kit colorimetric dipstick rapid :
    • ,
  • Urine pH IVD kit colorimetric dipstick rapid :
    • ,
  • Urine protein IVD kit colorimetric dipstick rapid :
    • ,
  • Urine specific gravity IVD kit colorimetric dipstick rapid :
    • ,
  • Urine urobilinogen IVD kit colorimetric dipstick rapid :
    • ,
  • Urine analyser IVD laboratory semi-automated :
    • ,
  • Multiple urine analyte IVD control :
Acorn Dental Laboratory.Acorn Dental Laboratory The Rosery
Weston Lane
Coventry
Warwickshire CV8 3BN

England United Kingdom
01926 423244
mandylifeboat@gmail.com





08/25/993357
  • Temporary dental crown/bridge :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Dental appliance fabrication material thermoplastic :
    • ,
  • Dental prosthesis bite verification device :
    • ,
  • Dental veneer professional :
    • ,
  • Resin dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Custom-made mouthguard :
    • ,
  • Mouthguard reusable :
    • ,
  • Preformed complete denture :
    • ,
  • Root canal post custom-made :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Orthodontic retainer :
    • ,
  • Partial denture :
    • ,
  • Dental bridge polymer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Overdenture :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Custom-made dental crown ceramic :
Acorn Mobility Services LimitedTelecom House Millennium Business Park

Steeton
West Yorkshire BD20 6RB

United Kingdom





10/16/20199144
  • Stairlift chair :
Acorn Polymers (UK) LtdVictoria Works Nelson Street

Bolton
Lancashire BL3 2DW

England United Kingdom





11/12/20091623
  • Dental impression tray single-use :
    • ,
  • Orthodontic Materials (Extra-Oral/Intra-Oral Transient And Short-Term Use) :
    • ,
  • Impression Materials Trays And Adhesives / Bite Wafers / Bite Gauge :
    • ,
  • Waxes :
    • ,
  • Dental Unit Accessories :
    • ,
  • Dental Appliances/Prostheses :
ACRA-CUT Inc.989 Main Street

Acton
MA 01720

United States

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
01/14/202111395
  • Cranial trephine single-use :
    • ,
  • Scalp clip applier reusable :
Acro Biotech Inc.4650 Arrow Highway Suite D-6

Montclair
CA 91763

United States

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
04/26/202113601
  • Amphetamine-specific IVD kit rapid ICT clinical :
    • ,
  • Ketamine/ketamine metabolite IVD kit enzyme immunoassay (EIA) :
    • ,
  • Methamphetamine-specific IVD kit rapid ICT clinical :
    • ,
  • Opiate/opiate metabolite IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapid :
    • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
    • ,
  • Multiple alcohol IVD kit rapid ICT clinical :
    • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
    • ,
  • Benzodiazepine group IVD kit rapid ICT clinical :
    • ,
  • Cocaine/cocaine metabolite IVD kit rapid ICT clinical :
    • ,
  • Cotinine IVD kit rapid ICT clinical :
    • ,
  • Amphetamine/methamphetamine group IVD kit rapid ICT clinical :
    • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
    • ,
  • D-dimer IVD kit rapid ICT clinical :
    • ,
  • Streptococcus pneumoniae antigen IVD kit rapid ICT clinical :
    • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
    • ,
  • Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinical :
    • ,
  • Salmonella typhi antigen IVD kit rapid ICT clinical :
    • ,
  • Calprotectin IVD kit rapid ICT clinical :
    • ,
  • Lactoferrin IVD kit rapid ICT clinical :
    • ,
  • Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical :
    • ,
  • Multiple form 25-hydroxy vitamin D IVD kit rapid ICT clinical :
    • ,
  • Cancer antigen 125 (CA125) IVD kit rapid ICT clinical :
    • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit rapid ICT clinical :
    • ,
  • Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinical :
    • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
    • ,
  • Pregabalin IVD kit rapid ICT clinical :
    • ,
  • Neisseria gonorrhoeae antigen IVD kit rapid ICT clinical :
    • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD reagent :
    • ,
  • Beta-haemolytic Group B Streptococcus antigen IVD kit rapid ICT clinical :
    • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
    • ,
  • Ethyl glucuronide (EtG) IVD reagent :
    • ,
  • Gamma-hydroxybutyrate (GHB) IVD reagent :
    • ,
  • Morphine/morphine metabolite IVD kit rapid ICT clinical :
    • ,
  • Methadone IVD kit rapid ICT clinical :
    • ,
  • Phencyclidine (PCP) IVD kit rapid ICT clinical :
    • ,
  • Cannabinoid IVD kit rapid ICT clinical :
    • ,
  • Tricyclic antidepressant IVD kit rapid ICT clinical :
    • ,
  • Candida albicans antigen IVD reagent :
    • ,
  • Multiple Campylobacter species antigen IVD kit rapid ICT clinical :
    • ,
  • Dengue virus NS1 antigen IVD kit rapid ICT clinical :
    • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
    • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
    • ,
  • Legionella pneumophila antigen IVD kit rapid ICT clinical :
    • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
    • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
    • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
Acro Diagnostics Co. Ltd.Room 8106 and 8107 Floor1 Building3 Yongchang Industrial Park No.3 Yongchang North Road BDA

Beijing
100176

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com		06/24/202115451
  • SARS-CoV-2 neutralizing antibody IVD kit enzyme immunoassay (EIA) :
ACROSS Co. Ltd.4F RD& Center 23 Geodudanji 1-gil Dongnae-myeon

Chuncheon-si
Gangwon-do 24398

South Korea

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/19/202114824
  • Dermal tissue reconstructive material microbe-derived anaesthetic :
    • ,
  • Dermal tissue reconstructive material microbe-derived :
Acrostak AGStegackerstrasse 14

Winterthur
8409

Switzerland

QAdvis UK LtdUK Responsible Person55-66 Frederick Street

Edinburgh EH2 1LS
EH2 1LS
UK Responsible Person
Scotland United Kingdom
05/03/202215321
  • Coronary angioplasty balloon catheter perfusing :
    • ,
  • Peripheral angioplasty balloon catheter basic :
    • ,
  • Vascular guide-catheter single-use :
Acrylic Services13 High Beeches

Banstead
Surrey SM7 1NB

United Kingdom





05/21/20091891
  • Temporary dental crown/bridge resin :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implantation drilling template custom-made :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Gold dental inlay :
    • ,
  • Dental implant x-ray template :
    • ,
  • Dental appliance fabrication material resin :
    • ,
  • Partial denture :
    • ,
  • Complete upper denture :
    • ,
  • Complete lower denture :
    • ,
  • Dental Appliances/Prostheses :
Actelion Pharmaceuticals LtdGewerbestrasse 16 CH-4123 Allschwil

Allschwil
CH-4123

Switzerland

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

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
01/06/202221066
  • Blood test-based differential diagnosis interpretive software IVD :
Actesso Medical Supports LtdUnit H7 Hermes Daedalus Park
Daedalus Drive
Lee-on-the-Solent
Hampshire PO13 9FX

United Kingdom





07/21/20155253
  • Orthoses (Lower And Upper Limb/Spinal/Abdominal/Neck/Head) :
    • ,
  • Orthopaedic Casting/Support Products And Accessories :
    • ,
  • Compression Hosiery/Garments :
    • ,
  • Postural Support Products :
    • ,
  • Orthopaedic Footware :
    • ,
  • Shoulder/elbow/wrist/hand orthosis :
    • ,
  • Wrist orthosis :
    • ,
  • Lumbar spine orthosis :
    • ,
  • Postsurgical head/neck garment :
    • ,
  • Hip/knee/ankle/foot orthosis :
Action Products Inc.954 Sweeney Dr

Hagerstown
Maryland 21740

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/01/202221865
  • Wheelchair seat cushion :
    • ,
  • Medical equipment drape single-use :
    • ,
  • Operating table patient pressure distribution pad reusable :
    • ,
  • Elbow/ankle friction/impact protector :
    • ,
  • Stool cushion :
    • ,
  • Operating table mattress basic :
    • ,
  • Heel stirrup cushion/pad :
    • ,
  • Toilet cushion :
    • ,
  • Wheelchair back rest :
    • ,
  • Gel-filled chair cushion :
    • ,
  • Gel-filled bed mattress overlay :
    • ,
  • Radiation therapy bolus single-use :
    • ,
  • Radiation therapy bolus reusable :
    • ,
  • Freestanding headrest reusable :
    • ,
  • Freestanding patient positioner reusable :
    • ,
  • Mattress repair patch :
    • ,
  • Medical cushion cover :
    • ,
  • Wheelchair tray pressure pad :
Active Dental Laboratory Ltd89 Westy Lane

Warrington
Cheshire WA4 1QY

England United Kingdom





06/08/20115785
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Orthodontic retainer :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Partial denture :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Ceramic dental inlay :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Overdenture :
    • ,
  • Dental implant suprastructure temporary custom-made :
    • ,
  • Dental impression tray reusable :
    • ,
  • Surgical drill guide reusable :
Active Design LimitedUnit K 68 Sapcote Trading Centre Wyrley Road Witton

Birmingham
West Midlands B6 7BN

United Kingdom





04/03/20221450
  • Postural Support Products :
Active Health Tech Ltd10 Cedar Avenue

Barnet
Hertfordshire EN4 8DY

United Kingdom





11/22/20199271
  • Patient general health self-management software :
Active Implants Israel Ltd.43 Hamelacha Street Sapir Industrial Park South

Natanya
42505

Israel

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/21/202113661
  • Orthopaedic surgical procedure kit non-medicated single-use :
    • ,
  • Meniscus prosthesis :
    • ,
  • Arthroscopic surgical procedure kit non-medicated reusable :
Acto GmbHSchulstrasse 8
Schulstr. Wietzen
Nienburg (Weser)
Hannover 31613

Germany

Creed Medical LtdUK Responsible PersonSynergy House Commercial Gate

Mansfield
Nottinghamshire NG18 1EX
UK Responsible Person
England United Kingdom
02/01/202221954
  • Antimicrobial wound irrigation solution non-sterile :
    • ,
  • Wound hydrogel dressing antimicrobial :
AcuFocus Inc.32 Discovery Suite 200

Irvine
CA92618

United States

Medpace UK Ltd.UK Responsible PersonVintners Place 68 Upper Thames St Queenhithe

London
EC4V 3BJ
UK Responsible Person
England United Kingdom
04/27/202114027
  • Posterior-chamber intraocular lens pseudophakic extended-focus :
    • ,
  • Posterior-chamber intraocular lens pseudophakic extended-focus :
Acuitis Optical and Hearing Exeter LTD193 High Street

Exeter
EX4 3DU

United Kingdom





04/15/202211026
  • Prescription spectacles :
ACUITY CONTACT LENSESUNIT 17 PLUMPTON HOUSE
PLUMPTON ROAD
HODDESDON
HERTFORDSHIRE EN110LB

United Kingdom





01/28/20198453
  • Soft corrective contact lens daily-wear :
    • ,
  • Rigid-gas-permeable corrective contact lens daily-wear :
ACUMEDIC LTD101-103 Camden High Street
London
London
London NW1 7JN

England United Kingdom





07/12/202116032
  • Acupuncture needle single-use :
Acurable LimitedFinsgate 5-7 Cranwood Street

LONDON
EC1V 9EE

United Kingdom





11/04/202010797
  • Wearable multiple physiological parameter recorder :
Acutronic Medical System AGFabrik im Schiffli

Hirzel
8816

Switzerland

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

Basingstoke
RG24 8NA
UK Responsible Person
England United Kingdom
09/15/202117529
  • Neonatal intensive-care ventilator :
    • ,
  • Breathing circuit gas-flow sensor reusable :
    • ,
  • Breathing circuit gas-flow sensor single-use :
Acutus Medical Inc.2210 Faraday Avenue Suite 100

Carlsbad
California 92008

United States

Acutus Medical UK LimitedUK Responsible PersonHill House 1 Little New Street

London
EC1A 3TR
UK Responsible Person
England United Kingdom
04/27/202224377
  • Cardiac mapping/ultrasound imaging catheter :
    • ,
  • Cardiac mapping system :
    • ,
  • Cardiac transseptal access set :
    • ,
  • Electrical-only medical device connection cable reusable :
    • ,
  • Catheter-tip-to-tissue contact monitor :
    • ,
  • Vascular catheter introduction set nonimplantable :
    • ,
  • Cardiac radio-frequency ablation system catheter :
    • ,
  • Cardiac transseptal access electrosurgical dilator/needle :
    • ,
  • Cardiac mapping system reference patch :
    • ,
  • Vascular guide-catheter single-use :
Acutus Medical UK LimitedHill House 1 Little New Street

London
EC1A 3TR

England United Kingdom





03/01/202223330
  • Vascular guide-catheter single-use :
Ad-Tech Medical Instrument Corporation400 West Oakview Parkway

Oak Creek
WI 53154

United States

Responsible Person LtdUK Responsible PersonSummit House 4-5 Mitchell Street

Edinburgh
EH6 7BD
UK Responsible Person
Scotland United Kingdom
04/12/202215439
  • Subdermal needle electrode :
    • ,
  • Neurological stereotactic surgery system :
    • ,
  • Depth electrode :
    • ,
  • Cortical electrode :
    • ,
  • Fluted surgical drill bit single-use :
    • ,
  • Wire/ligature passer reusable :
    • ,
  • Fluted surgical drill bit single-use :
    • ,
  • Subdermal needle electrode :
    • ,
  • Orthopaedic wire crimper :
    • ,
  • Surgical torque wrench reusable :
    • ,
  • Analytical scalp lead :
    • ,
  • Neurological stereotactic surgery system :
    • ,
  • Surgical torque wrench reusable :
    • ,
  • Analytical scalp lead :
    • ,
  • Electronic device storage cover single-use :
    • ,
  • Analytical scalp lead :
    • ,
  • Neurological stereotactic surgery system :
    • ,
  • Orthopaedic wire crimper :
Ad Rem Technology162 Rue du Faubourg Saint-Honore

Paris
75008

France

Win Health Medical LtdUK Responsible PersonUnit 1 Oxnam Road Industrial Estate
Jedburgh
Jedburgh
TD8 6LS
UK Responsible Person
United Kingdom
04/14/202217157
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
    • ,
  • Neuromuscular transmission electrode :
Ada Health GmbHKarl-Liebknecht-Str. 1
Karl-Liebknecht-Str. 1 Berlin
Berlin
Berlin 10178

Germany

Ada Digital Health Ltd.UK Responsible PersonInternational House 64 Nile Street

London
N1 7SR
UK Responsible Person
England United Kingdom
12/29/202121509
  • Patient general health self-management software :
Adagio Medical Inc.25051 Merit Circle Suite 102

Laguna Hills
CA 92653

United States

Medpace UK Ltd.UK Responsible PersonVintners Place 68 Upper Thames St Queenhithe

London
EC4V 3BJ
UK Responsible Person
England United Kingdom
03/23/202112718
  • Cardiac cryosurgical system :
    • ,
  • Oesophageal warming balloon catheter :
    • ,
  • Cardiac cryosurgical system catheter :
    • ,
  • Cardiac cryosurgical system catheter :
Adam Davies52 Ardwick Green South
GBR
MANCHESTER
Greater Manchester M13 9XF

United Kingdom





04/05/20222913
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental veneer professional :
    • ,
  • Gold dental inlay :
    • ,
  • Root canal post custom-made :
    • ,
  • Dental cusp permanent :
    • ,
  • Custom-made dental anatomy model :
    • ,
  • Custom-made organ/bone anatomy model/surgical guide kit :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Partial denture :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implant suprastructure temporary custom-made :
    • ,
  • Root canal post custom-made :
Adam LafosseGlebe House Idsworth

Waterlooville
Hampshire PO8 0AN

United Kingdom





03/21/20144688
  • Dental Appliances/Prostheses :
    • ,
  • Dental bridge ceramic :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Dental bridge polymer :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Dental veneer professional :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Bonded dental bridge :
    • ,
  • Ceramic dental inlay :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental prosthesis bite verification device :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental mould :
    • ,
  • Dental implant suprastructure permanent preformed :
    • ,
  • Dental implant suprastructure temporary preformed single-use :
    • ,
  • Overdenture :
    • ,
  • Bar dental precision attachment :
    • ,
  • Dental implant x-ray template :
    • ,
  • Vacuum mouldable splint :
    • ,
  • Dental guided surgery reference plate :
    • ,
  • Dental implant analog :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Surgical drill guide single-use :
    • ,
  • Root canal post custom-made :
    • ,
  • Sliding dental precision attachment :
    • ,
  • Dental prosthesis veneer resin :
Adam Norris Dental Laboratory Ltd123 Waterhouse Lane

Chelmsford
Essex CM1 2RY

England United Kingdom





06/19/20025708
  • Dental Appliances/Prostheses :
Adaptiiv Medical Technologies Inc.1344 Summer Street

Halifax
Nova Scotia B3H 0A8

Canada

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/18/202120150
  • Radiation therapy software :
Adaptive Biotechnologies Corporation1551 Eastlake Ave E

Seattle
Washington 98102

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/13/202221223
  • B-cell malignancy IVD kit nucleic acid technique (NAT) :
Adapttech LimitedSpaces 156 Great Charles St.
Queensway
Birmingham
B3 3HN

England United Kingdom

support@adapttech.eu





01/29/20198289
  • Biomechanical function analysis/rehabilitation software :
Adas3D Medical S.L.C/Paris 179

Barcelona
Barcelona 08036

Spain

Circle Cardiovascular Imaging UK LTDUK Responsible PersonTy Menter Navigation Park

Abercynon Mountain Ash
Mid Glamorgan CF45 4SN
UK Responsible Person
Wales United Kingdom
01/24/202222091
  • Surgical simulation system :
Adcal Dental Laboratory Ltd32 Cogan Street
Barrhead
Glasgow
East Renfrewshire G78 1EJ

Scotland United Kingdom
01418812547





04/07/20224441
  • Complete upper denture :
    • ,
  • Orthodontic clasp metal wire custom-made :
    • ,
  • Orthodontic clasp metal custom-made :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental prosthesis veneer resin :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made dental crown polymer :
    • ,
  • Temporary dental crown/bridge resin :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Bar dental precision attachment :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental implant suprastructure permanent preformed :
    • ,
  • Dental implant suprastructure temporary preformed reusable :
    • ,
  • Dental implant suprastructure temporary preformed single-use :
    • ,
  • Dental impression tray reusable :
    • ,
  • Dental impression tray single-use :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Dental occlusal splint customizable :
    • ,
  • Dental occlusal splint preformed reusable :
    • ,
  • Bonded dental bridge :
    • ,
  • Dental prosthesis bite verification device :
    • ,
  • Dental veneer professional :
    • ,
  • Gold dental inlay :
    • ,
  • Resin dental inlay :
    • ,
  • Preformed complete denture :
    • ,
  • Complete upper denture :
    • ,
  • Complete lower denture :
    • ,
  • Partial denture :
    • ,
  • Custom-made mouthguard :
    • ,
  • Denture clasp mould :
    • ,
  • Dental appliance fabrication material resin :
    • ,
  • Denture clasp metal custom-made :
    • ,
  • Denture clasp metal preformed :
    • ,
  • Denture clasp polymer preformed :
    • ,
  • Fluoride gel tray :
    • ,
  • Orthodontic appliance system bonded :
    • ,
  • Orthodontic retainer :
    • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
    • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
    • ,
  • Dental appliance fabrication material thermoplastic :
    • ,
  • Dental base plate :
    • ,
  • Dental bridge ceramic :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
Addiscombe Orthodontics242 Lower Addiscombe Road 202 Lower Addiscombe Road

Croydon
Surrey CR0 7AB

United Kingdom





04/09/20226019
  • Dental Appliances/Prostheses :
AdEchoTech7 rue du clos haut de la bouchardiere

Naveil
41 100

France

SENSUS Group LtdUK Responsible PersonThe Barn Tednambury Farm
Tednambury
Spellbrook
Hertfordshire CM23 4BD
UK Responsible Person
England United Kingdom
05/04/202215881
  • Video consultation telemedicine system :
Adelphi (Tubes) LtdOlympus House Mill Green Road

Haywards Heath
West Sussex RH16 1XQ

England United Kingdom





04/08/20224954
  • Intravenous administration bag/bottle :
adeor medical AGMartinshof 5

Valley
83626

Germany

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
05/25/202224762
  • Intrauterine device removal hook reusable :
    • ,
  • Automatic cranial perforator single-use :
    • ,
  • Intrauterine curette manual :
    • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar single-use :
    • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
    • ,
  • Clamp manipulation forceps :
    • ,
  • Gynaecological scissors reusable :
    • ,
  • Suturing needle holder reusable :
Adept Dental Laboratory Ltd84 Hollow Road
Bury St Edmunds
BURY ST. EDMUNDS
Suffolk IP32 7AZ

England United Kingdom

admin@adeptlabs.co.uk





12/11/20091930
  • Dental bridge ceramic :
    • ,
  • Preformed dental crown temporary :
    • ,
  • Preformed dental crown permanent :
    • ,
  • Temporary dental crown/bridge :
    • ,
  • Gold dental inlay :
    • ,
  • Bonded dental bridge :
    • ,
  • Ceramic dental inlay :
    • ,
  • Complete lower denture :
    • ,
  • Complete upper denture :
    • ,
  • Custom-made dental crown ceramic :
    • ,
  • Custom-made dental crown metal :
    • ,
  • Custom-made dental crown metal/ceramic :
    • ,
  • Custom-made dental crown metal/polymer :
    • ,
  • Custom-made mouthguard :
    • ,
  • Dental bridge metal-ceramic :
    • ,
  • Dental bridge metal-polymer :
    • ,
  • Dental bridge polymer :
    • ,
  • Dental implant abutment analog laboratory :
    • ,
  • Dental implant abutment analog scanning :
    • ,
  • Dental implant suprastructure permanent custom-made :
    • ,
  • Dental occlusal splint custom-made :
    • ,
  • Orthodontic retainer :
    • ,
  • Overdenture :
    • ,
  • Partial denture :
    • ,
  • Preformed complete denture :
    • ,
  • Resin dental inlay :
    • ,
  • Root canal post custom-made :
Adept Water Technologies A/SMileparken 22

Skovlunde
2740

Denmark

Durr Dental (Products) UK LtdUK Responsible Person14 Linnell Way Telford Way Industrial Estate

Kettering
Northamptonshire NN16 8PS
UK Responsible Person
England United Kingdom
12/22/202120832
  • Combination water purification system :
Adherium (NZ) Ltd.level 11 16 Kingston Street

Auckland
1010

New Zealand

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/22/202121464
  • Inhaler dose sensor :
Adhezion Biomedical LLC506 Pine Mountain Road

Hudson
North Carolina 28638

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/03/202222674
  • Skin-approximation adhesive :
    • ,
  • Surgical skin microbial sealant :