Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
BFB Labs LtdShift Design 71 St. John Street
2nd Floor
LONDON
EC1M 4NJ

United Kingdom







05/21/202010054
  • Mindfulness/behavioural therapy software clinician-consultative :
BGI Europe A/SOle Maaløes Vej 3

Copenhagen
DK-2200

Denmark

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
09/07/202117963
  • Human genomic analysis interpretive software :
  • ,
  • Nucleic acid library construction kit IVD :
  • ,
  • Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Evacuated blood collection tube transport container IVD :
  • ,
  • Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
  • ,
  • Human genomic analysis interpretive software IVD :
  • ,
  • Human infectome analysis interpretive software IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
BGI HEALTH (HK) COMPANY LIMITED3/F 16 Dai Fu Street Tai Po Industrial Estate Tai Po New Territories

Hong Kong
999077

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
06/13/202224891
  • Multiple Orthopoxvirus nucleic acid IVD kit nucleic acid technique (NAT) :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223937
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-430

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223940
  • Tibia nail non-sterile :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223941
  • Orthopaedic bone pin non-bioabsorbable :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223942
  • Orthopaedic bone wire :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223943
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
BHH Mikromed Sp Z o. o.Ul. Katowicka 11 Dabrowa Górnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223944
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
BHH Mikromed Sp. Z o. oUl. Katowicka 11 Dabrowa Gorrnicza

Dabrowa
45-530

Poland

IdealMed LimitedUK Responsible PersonUnit A2 Beech House Oaklands Office Park Hooton Road Hooton

Hooton
Cheshire CH66 7NZ
UK Responsible Person
England United Kingdom
04/11/202223936
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
BHM-Tech Produktionsgesellschaft mbHBHM-Tech Produktionsgesellschaft mbH Grafenschachen 242
7423 Grafenschachen
Grafenschachen
7423 Grafenschachen

Austria

Starkey Laboratories ltdUK Responsible PersonWilliam F Austin House Bramhall Technology Park
Pepper Road Hazel Grove
Stockport
Cheshire SK7 5BX
UK Responsible Person
United Kingdom
06/08/202115160
  • Bone-conduction hearing aid head-worn :
  • ,
  • Air-conduction hearing aid wearable case :
Bicester Dental Care98 sheep street

bicester
OX26 6LP

United Kingdom







11/21/20175731
  • Dental Appliances/Prostheses :
Bicon LLC501 Arborway
501 Arborway
Boston
MA 02130

United States

Bicon Marketing LimitedUK Responsible Person1 Abacus House Newlands Road

Corsham
Wiltshire SN13 0BH
UK Responsible Person
England United Kingdom
03/23/202213228
  • Basket endosteal dental implant two-piece :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental bone matrix implant synthetic :
  • ,
  • Instrument tray reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical mallet :
  • ,
  • Orthodontic pliers :
  • ,
  • General-purpose absorbent tip applicator/swab single-use :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Dental irrigation/aspiration syringe :
  • ,
  • Stationary x-ray grid :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental osteotome set :
  • ,
  • Dental osteotome :
  • ,
  • Dappen dish reusable :
  • ,
  • Root canal post thread cutter :
  • ,
  • Periotome reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental implant system :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental prosthesis/implant abutment screw :
Biedermann Motech GmbH & Co. KGBertha-von-Suttner Straße 23

Villingen-Schwenningen
Baden-Württemberg 78054

Germany

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

Wetherby
LS22 6LX
UK Responsible Person
England United Kingdom
05/09/202215436
  • Metallic spinal interbody fusion cage :
  • ,
  • Bone-screw internal spinal fixation system non-sterile :
  • ,
  • Bone-screw internal spinal fixation system non-sterile :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Vertebral body prosthesis :
  • ,
  • General internal orthopaedic fixation system implantation kit :
  • ,
  • General internal orthopaedic fixation system implantation kit :
  • ,
  • General internal orthopaedic fixation system implantation kit :
Bieffe Medital SpA trading as Baxter SondaloVia Stelvio 94

Sondalo
(SO) 23035

Italy

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
08/04/202116528
  • Haemodialysis concentrate :
  • ,
  • Haemodialysis concentrate :
  • ,
  • Haemodialysis citrate anticoagulation solution :
  • ,
  • Haemodialysis dialysate solution :
Biegler GmbHAllhangstrasse 18a

Mauerbach
3001

Austria

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL
UK Responsible Person
United Kingdom
04/13/202215971
  • Convection blood/fluid warmer set :
  • ,
  • Conduction blood/fluid warmer :
  • ,
  • Incentive spirometer :
  • ,
  • CNS-modulation periauricular nerve percutaneous electrical stimulator :
  • ,
  • Intravenous pressure infusor automated :
Bien-Air Dental SALänggasse 60

Bienne
2504

Switzerland

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

Horsham
West Sussex RH12 1DY
UK Responsible Person
England United Kingdom
10/06/202118054
  • Remotely-driven surgical/dental system drive cable :
  • ,
  • Dental power tool system handpiece remotely-driven :
  • ,
  • Remotely-driven dental drilling system motor :
  • ,
  • Pneumatic dental power tool hose :
  • ,
  • Dental power tool system handpiece pneumatic :
  • ,
  • Pneumatic dental handpiece coupler :
  • ,
  • Surgical instrument maintenance lubricant :
  • ,
  • Surgical power tool system control unit line-powered :
  • ,
  • Surgical power tool system control unit line-powered :
Bien-Air Surgery SABien-Air Surgery SA
Rue De L'ouest 2b
Le Noirmont
Jura 2340

Switzerland

Delta Surgical LimitedUK Responsible PersonUnit 10 Evolution Lymedale Business Park

Newcastle under Lyme
Staffordshire ST5 9QF
UK Responsible Person
United Kingdom
11/25/202117813
  • Middle ear drill bit :
  • ,
  • Cranial bur single-use :
  • ,
  • Metal/carbide ENT bur single-use :
  • ,
  • Diamond ENT bur reusable :
  • ,
  • Line-powered surgical power tool system motor :
  • ,
  • Metal/carbide ENT bur reusable :
  • ,
  • Diamond ENT bur single-use :
  • ,
  • Multi-purpose surgical power tool system rechargeable battery-powered :
  • ,
  • Drilling power tool attachment basic :
  • ,
  • Trephining power tool attachment :
  • ,
  • ENT shaver system :
  • ,
  • Surgical power tool system control unit line-powered :
  • ,
  • Craniotomy power tool system handpiece line-powered :
  • ,
  • Foot-switch electrical :
  • ,
  • Middle ear drill bit :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Multi-purpose surgical power tool system line-powered :
  • ,
  • ENT shaver system handpiece :
  • ,
  • ENT suction dissector :
Big Health Ltdc/o Simkins LLP Lynton House
7-12 Tavistock Square
LONDON
WC1H 9LT

United Kingdom







04/12/20228160
  • Cognitive training software :
BILIMETRIX s.r.l.AREA Science Park SNC Bldg. Q SS14 Km 163 5 – CAP 34149

Trieste
34149

Italy

IMed Consultancy Ltd UK Responsible PersonBloxham Mill Business centre Barford Road
Bloxham
Banbury
OX154FF
UK Responsible Person
England United Kingdom
03/10/202223540
  • Bilirubin monitoring system IVD :
Bill Jago Dental Laboratory Ltd6 Robins Park Loddiswell

Kingsbridge
Devon TQ7 4SL

United Kingdom







07/08/20113727
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Teeth whitening tray :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Root canal post custom-made :
  • ,
  • Partial denture :
  • ,
  • Overdenture :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Magnetic dental precision attachment :
  • ,
  • Bar dental precision attachment :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental veneer professional :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown ceramic :
Bimini Health Tech420 Stevens Ave Suite 220

Solana Beach
California 92075

United States

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
07/25/202225338
  • Haematological concentrate system preparation kit platelet concentration :
  • ,
  • Autologous adipose tissue collection/washing set :
Binding Sciences LimitedThe Seed House School Lane
Cropredy
Banbury
Oxfordshire OX17 1PX

England United Kingdom







03/08/202223504
  • Hand-held urinal reusable :
Bingley Dental ServicesLower Ground Clifby Works
Sandbeds Road Pellon
Halifax
West Yorkshire HX2 0QQ

United Kingdom







05/31/20134170
  • Dental Appliances/Prostheses :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Denture reliner elastic long-term :
  • ,
  • Denture reliner elastic short-term :
  • ,
  • Denture reliner hard :
  • ,
  • Overdenture :
  • ,
  • Denture reliner soft professional :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Partial denture :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim wax plate :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic clasp metal custom-made :
  • ,
  • Custom-made organ/bone anatomy model :
  • ,
  • Vacuum mouldable splint :
  • ,
  • Preformed complete denture :
  • ,
  • Bite registration rim :
  • ,
  • Custom-made mouthguard :
  • ,
  • Fluoride gel tray :
  • ,
  • Orthodontic retainer :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Denture clasp polymer preformed :
binx health LtdDerby Court Epsom Square White Horse Business Park

Trowbridge
Wiltshire BA14 0XG

United Kingdom







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

Sao Carlos
Sao Carlos 120 Jd. Tangara

Brazil

Panadent LimitedUK Responsible Person149 sevenoaks way

Orpington
Kent BR5 3AQ
UK Responsible Person
United Kingdom
08/12/202116748
  • Dental impression tray material :
  • ,
  • Facebow :
  • ,
  • Dental articulator :
  • ,
  • Magnifying spectacles :
Bio-Diagnostics LtdUpton Industrial Estate Rectory Road
Upton-upon-Severn
Worcester
Worcestershire WR8 0LX

United Kingdom







08/25/996957
  • Multi-purpose surgical skin adhesive tape :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
Bio-Rad Laboratories Inc. Clinical Immunology Division (CID)5500 East 2nd St.

Benicia
California 94510

United States

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221625
  • Treponema pallidum total antibody IVD kit fluorescent immunoassay :
  • ,
  • Treponema pallidum immunoglobulin G (IgG) antibody IVD calibrator :
  • ,
  • Treponema pallidum immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Multiple Coeliac disease-associated antibody IVD kit multiplex :
  • ,
  • Multiple Coeliac disease-associated antibody IVD calibrator :
  • ,
  • Multiple Coeliac disease-associated antibody IVD control :
  • ,
  • Multiple vasculitis-associated antibody IVD kit multiplex :
  • ,
  • Multiple vasculitis-associated antibody IVD control :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD kit multiplex :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD calibrator :
  • ,
  • Multiple vasculitis-associated antibody IVD calibrator :
  • ,
  • Phospholipid antibody IVD kit multiplex :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassay :
  • ,
  • Treponema pallidum reagin antibody IVD reagent :
  • ,
  • Multiplex analyser IVD laboratory automated :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD calibrator :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD reagent :
  • ,
  • Multiple liver disease-associated antibody IVD control :
  • ,
  • Multiple liver disease-associated antibody IVD kit fluorescent immunoassay :
  • ,
  • HIV1/HIV2 antigen/antibody IVD kit chemiluminescent immunoassay :
  • ,
  • HIV1/HIV2 antigen/antibody IVD control :
  • ,
  • HIV1/HIV2 antigen/antibody IVD calibrator :
  • ,
  • Microscope slide coverslip IVD :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD control :
Bio-Rad Laboratories Inc. Clinical Systems Division (CSD)4000 Alfred Nobel Drive

Hercules
94547

United States

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221626
  • Glycated haemoglobin (HbA1C) analyser IVD :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Haemoglobin A2 (HbA2) IVD reagent :
  • ,
  • Haemoglobin A2 (HbA2) IVD calibrator :
  • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
  • ,
  • Haemoglobin F (HbF) IVD calibrator :
  • ,
  • Inherited haemoglobinopathy IVD reagent :
  • ,
  • Opiate/opiate metabolite IVD kit rapid ICT clinical :
  • ,
  • Inherited haemoglobinopathy IVD kit liquid chromatography :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit liquid chromatography :
  • ,
  • Glycated haemoglobin (HbA1c) IVD reagent :
  • ,
  • High performance liquid chromatography analyser IVD automated :
Bio-Rad Laboratories Inc. (DBG - Digital Biology Group)5731 West Las Positas Blvd.

Pleasanton
California 94588

United States

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221628
  • Philadelphia chromosome/BCR-ABL transcript IVD primer :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automated :
  • ,
  • Nucleic acid amplification mastermix kit IVD :
Bio-Rad Laboratories Inc.Clinical Diagnostics Group 9500 Jeronimo Road

Irvine
California 92618-2017

United States

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221670
  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD control :
  • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Reticulocyte count IVD control :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Anti-Mullerian hormone (AMH) IVD control :
  • ,
  • Multiple biogenic amine neurotransmitter IVD control :
  • ,
  • HIV1 antibody IVD control :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD control :
  • ,
  • Multiple-therapy therapeutic drug monitoring IVD control :
  • ,
  • Multiple coagulation factor IVD control :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD control :
  • ,
  • Multiple immunosuppressant therapeutic drug monitoring IVD control :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Full blood count IVD control :
  • ,
  • Smooth muscle antibody IVD control :
  • ,
  • Treponema pallidum total antibody IVD control :
  • ,
  • D-dimer IVD control :
  • ,
  • HIV1/HIV2 antibody IVD control :
  • ,
  • Hepatitis B virus e-antigen IVD control :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD control :
  • ,
  • Multiple lipid analyte IVD control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD control :
  • ,
  • Multiple urine analyte IVD control :
  • ,
  • Multiple clinical chemistry protein IVD control :
  • ,
  • Multiple infectious organism/newborn TORCH screen IVD control :
  • ,
  • Multiple blood-borne virus antigen/antibody IVD control :
  • ,
  • Multiple tissue-associated protein/tumour marker IVD control :
  • ,
  • HIV1 antigen IVD control :
  • ,
  • Neisseria gonorrhoeae nucleic acid IVD control :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD control :
  • ,
  • Multiple infectious organism/newborn TORCH screen IVD kit rapid ICT clinical :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Erythrocyte sedimentation rate (ESR) IVD control :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Haemoglobin A2 (HbA2) IVD control :
  • ,
  • Rheumatoid factor IVD control :
  • ,
  • Lead IVD control :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD control :
  • ,
  • Homocysteine IVD control :
  • ,
  • Microalbumin IVD control :
  • ,
  • Multiple anaemia-related analyte IVD control :
  • ,
  • Multiple heavy metal IVD control :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD control :
  • ,
  • Ethanol (ETOH) IVD control :
  • ,
  • Multiple human hormone IVD control :
  • ,
  • Ammonia IVD control :
  • ,
  • C-reactive protein (CRP) IVD control :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD control :
  • ,
  • Multiple therapeutic drugs/drugs of abuse IVD control :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • MRSA nucleic acid IVD control :
  • ,
  • Multiple cardiac marker IVD control :
  • ,
  • SARS-CoV-2 total antibody IVD control :
Bio-Rad Laboratories Seattle Operations Redmond6565 185th Avenue NE

Redmond
Washington 98052

United States

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221673
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassay :
  • ,
  • Native DNA antibody (anti-nDNA) IVD reagent :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD reagent :
  • ,
  • Acid phosphatase isoenzyme IVD reagent :
Bio-Rad Medical Diagnostics GmbHIndustriestr.1

Dreieich
D-63303

Germany

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221631
  • Bromelin immunohaematology reagent IVD :
  • ,
  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD :
  • ,
  • Papain immunohaematology reagent IVD :
  • ,
  • Anti-A red blood cell grouping IVD antibody :
  • ,
  • Anti-K (KEL001) red blood cell grouping IVD antibody :
  • ,
  • Anti-AB red blood cell grouping IVD antibody :
  • ,
  • Anti-Rh(D) red blood cell grouping IVD antibody :
  • ,
  • Anti-C [RH004] red blood cell grouping IVD antibody :
  • ,
  • Anti-B red blood cell grouping IVD antibody :
  • ,
  • Anti-C [RH002] red blood cell grouping IVD antibody :
  • ,
  • Anti-E [RH003] red blood cell grouping IVD antibody :
  • ,
  • Anti-E [RH005] red blood cell grouping IVD antibody :
  • ,
  • Anti-Jk^a red blood cell grouping IVD antibody :
  • ,
  • Antisera matrix (non-reactive) IVD control :
  • ,
  • Anti-Jk^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Fy^b red blood cell grouping IVD antibody :
  • ,
  • Monospecific anti-complement component C3 (anti-C3) IVD antibody :
  • ,
  • Monospecific anti-complement component C3d (anti-C3d) IVD antibody :
  • ,
  • Complement components C4/C4c IVD antibody :
  • ,
  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD antibody :
  • ,
  • Antibody identification panel reagent red blood cell IVD kit agglutination :
  • ,
  • HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Group AB serum IVD control :
  • ,
  • HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Polyspecific antihuman globulin/complement IVD antibody :
  • ,
  • Anti-Fy^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Kp^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Kp^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Le^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Le^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Lu^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Lu^b red blood cell grouping IVD antibody :
  • ,
  • Anti-M red blood cell grouping IVD antibody :
  • ,
  • Anti-N red blood cell grouping IVD antibody :
  • ,
  • Anti-P1 red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS003] red blood cell grouping IVD antibody :
  • ,
  • Anti-Wr^a red blood cell grouping IVD antibody :
  • ,
  • Bovine serum albumin (BSA) immunohaematology reagent IVD :
  • ,
  • Anti-CDE red blood cell grouping IVD antibody :
  • ,
  • ABO/Rh multiple blood grouping IVD kit agglutination :
  • ,
  • Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD kit agglutination :
  • ,
  • Anti-Xg^a red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS004] red blood cell grouping IVD antibody :
  • ,
  • Anti-C^w red blood cell grouping IVD antibody :
Bio-Rad3 boulevard Raymond Poincaré

Marnes-la-Coquette
92430

France

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

WATFORD
Hertfordshire wd17 1et
UK Responsible Person
England United Kingdom
05/13/202221629
  • HIV1 antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1 antigen neutralization IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1 antibody IVD kit immunoblot :
  • ,
  • Hepatitis C virus total antibody IVD kit immunoblot :
  • ,
  • Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antibody IVD control :
  • ,
  • Hepatitis C virus total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus e-antigen/antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis C virus antibody/antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis C virus total antibody IVD kit rapid ICT clinical :
  • ,
  • Hepatitis C virus total antibody IVD control :
  • ,
  • Vibrio cholerae antigen (multiple serotype) IVD kit agglutination :
  • ,
  • Multiple Salmonella species culture isolate antigen IVD kit agglutination :
  • ,
  • Escherichia coli antigen IVD kit agglutination :
  • ,
  • Neisseria meningitidis culture isolate antigen IVD kit agglutination :
  • ,
  • Multiple Shigella species culture isolate antigen IVD kit agglutination :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
  • ,
  • Leishmania species immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple Plasmodium species antigen IVD control :
  • ,
  • General-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Fungal antimicrobial susceptibility culture medium IVD :
  • ,
  • Antifungal susceptibility testing disc IVD :
  • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dengue virus NS1 antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antibody IVD kit rapid ICT clinical :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple meningitis-associated bacteria antigen IVD kit agglutination :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species immunoglobulin M (IgM) antibody IVD reagent :
  • ,
  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Novobiocin differentiation disc IVD :
  • ,
  • Optochin/ethylhydrocupreine differentiation disc IVD :
  • ,
  • Bacitracin differentiation disc IVD :
  • ,
  • SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Enzyme immunoassay (EIA) analyser IVD automated :
  • ,
  • Microplate washer IVD automated :
  • ,
  • Multiple Candida/yeast species culture isolate identification IVD kit :
  • ,
  • Beta-haemolytic Streptococcus serological grouping IVD kit agglutination :
  • ,
  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD kit :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis A virus total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Staphylococcus aureus culture isolate antigen IVD kit agglutination :
  • ,
  • Treponema pallidum total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum reagin antibody IVD kit agglutination :
  • ,
  • Antimicrobial susceptibility analyser IVD automated :
  • ,
  • Dengue virus NS1 antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple bacteria carbapenemase production IVD kit chromogenic :
  • ,
  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Candida species mannan antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD control :
  • ,
  • Antibacterial susceptibility testing disc IVD :
  • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Enriched broth culture medium IVD :
  • ,
  • Microplate/assay card incubator IVD :
  • ,
  • Coagulase production microbial reagent IVD :
  • ,
  • Antimicrobial activity testing agar culture medium IVD :
  • ,
  • Multiple Aspergillus species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Differential/selective agar culture medium IVD :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum total antibody IVD kit agglutination :
Bio-Sensing Solutions S.L.Avenida Meridiana 354 Floor 2 Office CD

Barcelona
08027

Spain

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
06/14/202224841
  • Biomechanical function analysis/rehabilitation software :
BIO-TECH VISION CARE PVT. LTD.Plot No. 555-556-557 Opp. Subham Tex-OPack Khatraj-Vadsar Road P.O.: Khatraj
Taluka Kalol Dist. Gandhinagar Gujarat
Gandhinagar
382721

India

BIOTECH UK HEALTHCARE LIMITEDUK Responsible Person25 Leeming Road

Borehamwood
Hertfordshire WD6 4EB
UK Responsible Person
England United Kingdom
04/30/202114226
  • Dermal tissue reconstructive material microbe-derived :
  • ,
  • Vitreous/aqueous humour replacement medium intraoperative :
  • ,
  • Ophthalmic surgical dye :
  • ,
  • Vitreous/aqueous humour replacement medium intraoperative :
  • ,
  • Intracorneal ring segment :
  • ,
  • Synovial fluid supplementation medium :
  • ,
  • Bladder instillation barrier :
  • ,
  • Anterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Capsular tension ring :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Intraocular retractor single-use :
  • ,
  • Schirmer tear test strip :
  • ,
  • Corneal staining strip :
  • ,
  • Manual intraocular lens injector single-use :
  • ,
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Vitreous humour replacement medium postoperative :
Bio-Technology General Ltd.Be'er Tuvia Industrial Zone P.O. Box 571

Kiryat Malachi 8310402
8310402

Israel

Ferring Pharmaceuticals LtdUK Responsible PersonDrayton Hall Church Road
West Drayton
West Drayton
UB7 7PS
UK Responsible Person
England United Kingdom
01/18/202219336
  • Synovial fluid supplementation medium :
  • ,
  • Vitreous/aqueous humour replacement medium intraoperative :
Bio Composants Medicaux15 route de Bavonne

Saint Blaise du Buis
38140

France

ALS International Ltd Trading as I3CGLOBAL(UK)UK Responsible PersonOffice 54 58 Peregrine Road
Hainault
Ilford
Essex IG6 3SZ
UK Responsible Person
England United Kingdom
05/05/202224518
  • Dental reinforcing fibre :
  • ,
  • Root canal post preformed :
  • ,
  • Pin/post dental drill bit :
  • ,
  • Wax dental impression material :
Bio Compression Systems Inc120 W. Commercial Avenue

Moonachie
New Jersey 7074

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/18/202118385
  • Intermittent venous compression system :
  • ,
  • Single-chamber venous compression system garment reusable :
  • ,
  • Hot/cold therapy pack reusable :
  • ,
  • Multi-chamber venous compression system garment reusable :
  • ,
  • Intermittent venous compression system pump :
  • ,
  • Sequential venous compression system pump :
Bio Med Sciences Inc.7584 Morris CT Ste 218

Allentown
18106

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
03/22/202223777
  • Scar management dressing reusable :
  • ,
  • Wound-nonadherent dressing permeable non-antimicrobial :
Bio Molecular Systems Pty Ltd5-7 Tonka St

Yatala
QLD 4207

Australia

Bio Molecular Systems LtdUK Responsible Person22 Chancery Lane

London
WC2A 1LS
UK Responsible Person
England United Kingdom
01/17/202221280
  • Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automated :
Bio Optica Milano S.p.ABio-Optica Milano S.p.A
Via San Faustino 58 MILANO
MI
Lombardia 20134

Italy

AnatoPath LimitedUK Responsible PersonANATOPATH LTD London Road
The Haven
Saxmundham
Suffolk IP17 3QL
UK Responsible Person
England United Kingdom
11/12/202119064
  • Biopsy tissue marking dye kit IVD :
  • ,
  • Biological stain IVD :
  • ,
  • Histology tissue cassette IVD laboratory processing :
  • ,
  • Tissue embedding mould IVD reusable :
  • ,
  • Tissue embedding unit IVD :
  • ,
  • Microscope slide stainer IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Autopsy/dissection sink system :
  • ,
  • Laboratory water bath :
  • ,
  • Paraffin wax oven :
  • ,
  • General specimen container IVD additive/medium :
  • ,
  • Laboratory container robotic transfer system IVD automated :
  • ,
  • Histology/pathology tissue cutting board IVD :
  • ,
  • Instrument/analyser cleaning agent IVD :
  • ,
  • Tissue freezing/embedding medium IVD :
  • ,
  • Decalcifying solution IVD :
  • ,
  • Bouin's solution IVD :
  • ,
  • Neutral buffered formalin IVD :
  • ,
  • General specimen container IVD no additive/medium :
  • ,
  • Histology tissue processing reagent kit IVD :
  • ,
  • Reagent grade alcohol solution IVD :
  • ,
  • Xylene solution IVD :
  • ,
  • Histological tissue cassette biopsy insert IVD :
  • ,
  • Paraffin-based embedding medium IVD :
  • ,
  • Cryogenic tissue spray IVD :
  • ,
  • General specimen microscopy slide IVD single-use :
  • ,
  • Cytology fixative solution IVD :
  • ,
  • Centrifuge tube IVD :
  • ,
  • Microscope slide maker/stainer IVD automated :
  • ,
  • Microscope slide coverslipper IVD :
Bio Protech Inc.151-3 Donghwagongdan-ro Munmak-eup

Wonju-si Gangwon-do
26365

South Korea

DongBang AcuPrime LtdUK Responsible Person1 The Forrest Units Hennock Road East

Exeter
Devon EX2 8RU
UK Responsible Person
United Kingdom
05/05/202224474
  • Electromyographic needle electrode single-use :
  • ,
  • Electrosurgical return electrode single-use :
  • ,
  • Electrosurgical handpiece single-use :
  • ,
  • Surgical plume evacuation system :
  • ,
  • Electrocardiographic electrode single-use :
  • ,
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Transcutaneous electrical stimulation electrode single-use :
  • ,
  • Surgical plume evacuation system tube :
  • ,
  • Electroencephalographic electrode cap single-use :
Bioantibody Biotechnology Co. Ltd.Room 903/905 Building C6 9 Weidi Road Nanjing

Jiangsu Province
210046

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
07/25/202225380
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Monkeypox virus antigen IVD kit rapid ICT clinical :
  • ,
  • Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus NS1 antigen IVD kit rapid ICT clinical :
BioArray Solutions Ltd.35 Technology Drive Suite 100

Warren
New Jersey 07059

United States

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
04/29/202114170
  • Multiple blood group genotyping IVD reagent :
  • ,
  • HLA class I & II antigen tissue typing IVD kit multiplex :
  • ,
  • Multiple blood group genotyping IVD reagent :
Biocare Enterprise LtdFlat 01A 9/F Brill Plaza 84 Tokwawan Road Kowloon

Hong Kong
Hong Kong of China N/A

China

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
09/21/202117619
  • Musculoskeletal/physical therapy laser home-use :
Biocare Medical LLC60 Berry Drive

Pacheco
California 94553

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
02/01/202221674
  • Immunohistochemistry antigen retrieval reagent IVD :
  • ,
  • Microscope slide maker/stainer IVD automated :
  • ,
  • Buffered isotonic saline reagent IVD :
  • ,
  • Specimen preparation enzyme reagent IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Galectin-3 IVD kit enzyme immunohistochemistry :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Epstein-Barr virus (EBV) antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Human papillomavirus (HPV) antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Helicobacter pylori antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Pepsin IVD reagent :
  • ,
  • Trypsin IVD reagent :
  • ,
  • Vascular endothelial growth factor (VEGF) IVD kit enzyme immunohistochemistry :
  • ,
  • Human placental alkaline phosphatase (hPLAP) IVD kit enzyme immunohistochemistry :
  • ,
  • Amyloid A component IVD kit enzyme immunohistochemistry :
  • ,
  • Amyloid P component IVD kit enzyme immunohistochemistry :
  • ,
  • Anaplastic lymphoma kinase IVD kit enzyme immunohistochemistry :
  • ,
  • Androgen receptor IVD kit enzyme immunohistochemistry :
  • ,
  • Basal cell cocktail IVD antibody :
  • ,
  • B-cell specific activator protein (BSAP) IVD kit enzyme immunohistochemistry :
  • ,
  • B lymphocyte IVD kit enzyme immunohistochemistry :
  • ,
  • Bcl-2 oncoprotein IVD kit enzyme immunohistochemistry :
  • ,
  • Bcl-6 protein IVD kit enzyme immunohistochemistry :
  • ,
  • BRCA1 protein IVD kit enzyme immunohistochemistry :
  • ,
  • Breast carcinoma antigen 225 (BCA-225) IVD kit enzyme immunohistochemistry :
  • ,
  • E-cadherin epithelial marker IVD kit enzyme immunohistochemistry :
  • ,
  • Calcitonin IVD kit enzyme immunohistochemistry :
  • ,
  • Calponin protein IVD kit enzyme immunohistochemistry :
  • ,
  • Calretinin protein IVD kit enzyme immunohistochemistry :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD kit enzyme immunohistochemistry :
  • ,
  • Cancer antigen 125 (CA125) IVD kit enzyme immunohistochemistry :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit enzyme immunohistochemistry :
  • ,
  • Caspase-3 IVD kit enzyme immunohistochemistry :
  • ,
  • Beta-catenin IVD kit enzyme immunohistochemistry :
  • ,
  • CD1a cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD3 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD4 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD5 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD8 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD10 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD11c cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD15 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD19 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD20 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD21 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD22 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD23 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD28 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD30 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD31 endothelial cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD33 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD34 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD43 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD44 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD45 leukocyte common antigen cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD45RO cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD kit enzyme immunohistochemistry :
  • ,
  • CD56 neural cell adhesion molecule-1 (NCAM-1) IVD kit enzyme immunohistochemistry :
  • ,
  • CD57 natural killer cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD68 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD71 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD79a cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD99 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD103 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • CD117 (c-kit) cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • Chromogranin A IVD kit enzyme immunohistochemistry :
  • ,
  • CD138 cell marker IVD kit enzyme immunohistochemistry :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Collagen type IV IVD kit enzyme immunohistochemistry :
  • ,
  • Cox-2 IVD kit enzyme immunohistochemistry :
  • ,
  • Cyclin D1 IVD kit enzyme immunohistochemistry :
  • ,
  • Cytokeratin IVD kit enzyme immunohistochemistry :
  • ,
  • D2-40 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Desmin protein IVD kit enzyme immunohistochemistry :
  • ,
  • Epidermal growth factor receptor (EGFR) IVD kit enzyme immunohistochemistry :
  • ,
  • Epidermal growth factor receptor (EGFR) IVD antibody :
  • ,
  • Epithelial antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Epithelial membrane antigen (EMA) IVD kit enzyme immunohistochemistry :
  • ,
  • Epithelial specific antigen (ESA) IVD kit enzyme immunohistochemistry :
  • ,
  • Estrogen (oestrogen)/progesterone receptor IVD kit enzyme immunohistochemistry :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit enzyme immunohistochemistry :
  • ,
  • Glial fibrillary acidic protein (GFAP) IVD kit enzyme immunohistochemistry :
  • ,
  • Granzyme B IVD kit enzyme immunohistochemistry :
  • ,
  • Gross cystic disease fluid protein-15 IVD kit enzyme immunohistochemistry :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunohistochemistry :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD kit enzyme immunohistochemistry :
  • ,
  • Inhibin A IVD kit enzyme immunohistochemistry :
  • ,
  • Ki67 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Mammaglobin IVD kit enzyme immunohistochemistry :
  • ,
  • Melan-A/MART-1 peptide IVD kit enzyme immunohistochemistry :
  • ,
  • Melanosome IVD kit enzyme immunohistochemistry :
  • ,
  • Microphthalmia-associated transcription factor (MITF) IVD kit enzyme immunohistochemistry :
  • ,
  • MLH1 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • MSH2 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • MSH6 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Mucin IVD kit enzyme immunohistochemistry :
  • ,
  • MUM1 transcription factor IVD kit enzyme immunohistochemistry :
  • ,
  • Muscle-specific alpha/gamma actin IVD kit enzyme immunohistochemistry :
  • ,
  • Nerve growth factor receptor p75 IVD kit enzyme immunohistochemistry :
  • ,
  • Neurofilament protein IVD kit enzyme immunohistochemistry :
  • ,
  • p16 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • p501s IVD kit enzyme immunohistochemistry :
  • ,
  • p53 tumour protein IVD kit enzyme immunohistochemistry :
  • ,
  • p63 tumour protein IVD kit enzyme immunohistochemistry :
  • ,
  • Progesterone receptor IVD kit enzyme immunohistochemistry :
  • ,
  • Proliferating cell nuclear antigen (PCNA) IVD kit enzyme immunohistochemistry :
  • ,
  • Phosphatase and tensin homolog (PTEN) protein IVD kit enzyme immunohistochemistry :
  • ,
  • Smooth muscle actin IVD kit enzyme immunohistochemistry :
  • ,
  • Synaptophysin IVD kit enzyme immunohistochemistry :
  • ,
  • T-cell intracytoplasmic antigen (TIA1) IVD kit enzyme immunohistochemistry :
  • ,
  • Terminal deoxynucleotidyl transferase (TdT) IVD kit enzyme immunohistochemistry :
  • ,
  • Thyroid transcription factor-1 (TTF1) IVD kit enzyme immunohistochemistry :
  • ,
  • Tumour-associated glycoprotein-72 (TAG72) IVD kit enzyme immunohistochemistry :
  • ,
  • Tyrosinase IVD kit enzyme immunohistochemistry :
  • ,
  • Vimentin IVD kit enzyme immunohistochemistry :
  • ,
  • Wilms tumour protein IVD kit enzyme immunohistochemistry :
  • ,
  • Zeta chain associated protein kinase 70 (ZAP-70) IVD kit enzyme immunohistochemistry :
  • ,
  • Immunohistochemistry antibody detection IVD kit enzyme immunohistochemistry :
  • ,
  • Immunohistochemistry antibody diluent IVD :
  • ,
  • Immunohistochemistry endogenous enzyme blocking reagent IVD :
  • ,
  • Immunohistochemistry negative control (normal animal serum) IVD :
  • ,
  • Immunohistochemistry protease reagent IVD :
  • ,
  • Immunohistochemistry conjugated secondary antibody IVD :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • S100 protein IVD kit enzyme immunohistochemistry :
  • ,
  • Coagulation factor XIIIa pro-enzyme subunit IVD kit enzyme immunohistochemistry :
  • ,
  • Polymer-enzyme conjugate IVD reagent :
  • ,
  • Programmed death-ligand 1 (PD-L1) IVD kit enzyme immunohistochemistry :
  • ,
  • Desmoglein 3 (DSG3) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Detergent solution IVD :
  • ,
  • Napsin A IVD antibody :
  • ,
  • Postmeiotic segregation increased 2 (PMS2) IVD antibody :
  • ,
  • Mesothelin IVD antibody :
  • ,
  • Programmed death-1 (PD-1) IVD antibody :
  • ,
  • Uroplakin IVD antibody :
  • ,
  • Glucose transporter (GLUT) protein IVD antibody :
  • ,
  • Glypican-3 IVD antibody :
  • ,
  • Paired box protein (PAX) IVD antibody :
  • ,
  • Arginase IVD antibody :
  • ,
  • SOXE protein IVD antibody :
  • ,
  • SOXB1 protein IVD antibody :
  • ,
  • SOXC protein IVD antibody :
  • ,
  • Smoothelin IVD antibody :
  • ,
  • LIM-domain-only (LMO) protein IVD antibody :
  • ,
  • Sal-like protein 4 (SALL4) IVD antibody :
  • ,
  • Perilipin protein IVD antibody :
  • ,
  • GATA protein transcription factor IVD antibody :
  • ,
  • Glutamine synthetase IVD antibody :
  • ,
  • Treponema pallidum antigen IVD antibody :
  • ,
  • Signal transducer and activator of transcription (STAT) protein IVD antibody :
  • ,
  • Multiple breast tissue/tumour marker IVD antibody :
  • ,
  • Excision repair cross-complementing (ERCC) protein IVD antibody :
  • ,
  • Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD antibody :
  • ,
  • Isocitrate dehydrogenase 1 (IDH1) IVD antibody :
  • ,
  • Preferentially expressed antigen in melanoma (PRAME) IVD antibody :
  • ,
  • Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD antibody :
  • ,
  • SMAD4 protein IVD antibody :
  • ,
  • Microscope slide maker/digital imaging analyser IVD :
  • ,
  • CD163 cell marker IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dewaxing solution IVD :
  • ,
  • NKX protein IVD antibody :
  • ,
  • p40 protein IVD antibody :
  • ,
  • HIV1/HIV2/Mycobacterium tuberculosis antibody IVD reagent :
  • ,
  • Adenovirus immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Insulin-like growth factor I (IGF1) IVD reagent :
  • ,
  • Alpha-fetoprotein (AFP) IVD antibody :
  • ,
  • Cytokeratin IVD antibody :
  • ,
  • BRAF V600 gene mutation IVD reagent :
  • ,
  • Interferon gamma release IVD reagent :
  • ,
  • Histone protein IVD antibody :
  • ,
  • Insulin-like growth factor II mRNA binding protein 3 (IMP3) IVD antibody :
  • ,
  • Immunohistochemistry antibody detection IVD reagent :
  • ,
  • Immunohistochemistry endogenous protein blocking reagent IVD :
  • ,
  • CD235a glycophorin A red blood cell marker IVD antibody :
  • ,
  • HLA-DR antigen tissue typing IVD kit enzyme immunohistochemistry :
  • ,
  • Polyvalent human immunoglobulin antibody IVD kit enzyme immunohistochemistry :
  • ,
  • Decalcifying solution IVD :
  • ,
  • Nucleic acid hybridization detection IVD reagent :
  • ,
  • Biological stain IVD :
  • ,
  • Hepatocyte specific antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Myeloperoxidase (MPO) IVD kit enzyme immunohistochemistry :
  • ,
  • Myogenin IVD kit enzyme immunohistochemistry :
  • ,
  • Folate receptor alpha (FRa) IVD antibody :
  • ,
  • Heat shock protein IVD antibody :
  • ,
  • Glucagon IVD antibody :
  • ,
  • CD19 cell marker IVD antibody :
Biocartis NVGeneraal De Wittelaan 11 B3

Mechelen
2800

Belgium

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/29/202121609
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
  • ,
  • BRAF V600 gene mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • KRAS gene mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • Microsatellite instability IVD kit nucleic acid technique (NAT) :
  • ,
  • Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple human coronavirus nucleic acid IVD kit nucleic acid technique (NAT) :
Biocentric SAS276 chemin de Roumpinas
BANDOL
Toulon
Var 83150

France

Bruker UK LimitedUK Responsible PersonBanner Lane

Coventry
CV4 9GH
UK Responsible Person
England United Kingdom
04/22/202221434
  • Antibacterial minimum inhibitory concentration (MIC) IVD :
  • ,
  • Mueller-Hinton broth antimicrobial susceptibility culture medium IVD :
BioCer Entwicklungs-GmbHLudwig-Thoma-Strasse 36c

Bayreuth
Bavaria 95447

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202215811
  • Plant polysaccharide haemostatic agent bioabsorbable :
  • ,
  • Multi-purpose surgical mesh synthetic polymer non-bioabsorbable non-antimicrobial :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
BioceramedRua Jose Gomes Ferreira 1 Arm D

Loures
Sao Juliao do Tojal 2660-360

Portugal

Osteon Medical LtdUK Responsible Person133 Tame Road Birmingham

Birmingham
B67DG
UK Responsible Person
England United Kingdom
07/13/202225154
  • Synthetic bone graft :
Biochemical Diagnostics Inc180 Heartland Blvd.

Edgewood
New York 11779

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
12/29/202121583
  • Human chorionic gonadotropin beta-core fragment IVD control :
  • ,
  • Multiple drugs of abuse IVD control :
  • ,
  • Ethyl glucuronide (EtG) IVD control :
Biochrom LtdUnit 7 Enterprise Zone 3970 Cambridge Research Park
Beach Drive Waterbeach
Cambridge
Cambridgeshire CB25 9PE

England United Kingdom







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

Shenzhen
Guangdong 518118

China

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

London
W1H 1PJ
UK Responsible Person
United Kingdom
12/23/202120882
  • Oral/upper respiratory tract specimen collection swab :
  • ,
  • Nucleic acid sample preparation instrument IVD automated :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Oral/respiratory tract specimen container IVD additive/medium :
  • ,
  • Saliva collection mouthpiece IVD :
  • ,
  • Blood collection paper :
  • ,
  • Blood cell preservation/storage/dilution solution IVD :
  • ,
  • Oral/upper respiratory tract specimen collection kit IVD home-use :
  • ,
  • Microbial specimen inoculation/streaking/colony-picking instrument IVD :
Biocompatibles UK LimitedChapman House Weydon Lane
Chapman House GBR
FARNHAM
Surrey GU9 8QL

England United Kingdom







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

Newcastle
Staffordshire ST5 5NL

United Kingdom







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

Knypersley
Staffordshire ST8 7PP

England United Kingdom







01/28/202111835
  • Neisseria gonorrhoeae culture isolate identification IVD kit :
  • ,
  • Oxidase production microbial reagent IVD :
  • ,
  • Catalase production microbial reagent IVD :
  • ,
  • Multiple Neisseria species culture isolate identification IVD kit :
  • ,
  • Indole/Kovac's microbial reagent IVD :
  • ,
  • Differential/selective agar culture medium IVD :
  • ,
  • Hippurate hydrolase microbial reagent IVD :
  • ,
  • Urea differentiation disc IVD :
  • ,
  • Chromogenic substrate reagent IVD :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD reagent :
  • ,
  • Nitrate reduction microbial reagent IVD :
  • ,
  • Coagulase production microbial reagent IVD :
  • ,
  • Basic/simple nutrient agar culture medium IVD :
BioCytex S.a.r.l140 Chemin de l'Armée d'Afrique

Marseille
13010

France

Diagnostica Stago UKUK Responsible Person2 Theale Lakes Business Park Moulden Way
Sulhamstead
Theale
RG7 4GB
UK Responsible Person
England United Kingdom
03/07/202223449
  • Vasodilator-stimulated phosphoprotein (VASP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Vasodilator-stimulated phosphoprotein (VASP) IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
  • ,
  • Multiple platelet membrane glycoprotein IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
BioDerm Inc.12320 73rd Court North

Largo
Florida 33773

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
01/07/202219712
  • Incontinence penis clamp reusable :
  • ,
  • Wearable percutaneous catheter/tube holder :
  • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
  • ,
  • Patient medical adhesive remover :
  • ,
  • Penis wearable urinal :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • Urinary incontinence penis sheath/port single-use :
Biodex Medical Systems Inc.20 Ramsay Road

Shirley
New York 11967

United States

NB Insight LtdUK Responsible Person39 Lambourn Avenue Stone Cross
Pevensey
Pevensey
East Sussex BN24 5PQ
UK Responsible Person
England United Kingdom
12/17/202118978
  • Biomechanical function analysis system force-testing stationary :
  • ,
  • Standard treadmill powered :
  • ,
  • Basic diagnostic x-ray system table powered :
  • ,
  • Mobile gait rehabilitation system harness-support :
  • ,
  • Posturography system :
BioDue S.p.A.Via A. Lorenzetti 3/A Loc. sambuca Val di Pesa
50028 Barberino Tavarnelle
Florence
50028

Italy

Pettifor Healthcare LimitedUK Responsible PersonThe Homestead Barnby Road Balderton

Newark
Nottinghamshire NG24 3NE
UK Responsible Person
England United Kingdom
11/15/202119658
  • Eye lubricant :
BioElectronics Corporation4539 Metropolitan Court

Frederick MD
21704

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
07/13/202115888
  • Hand-held deep-tissue electromagnetic stimulator :
Bioengineering Laboratories SrlVia Antonio Vivaldi 32/A

Cantù
Como 22063

Italy

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX
UK Responsible Person
England United Kingdom
09/02/202117118
  • Gastrointestinal motility manometric catheter non-electronic :
  • ,
  • Urodynamic manometric catheter non-electronic :
  • ,
  • Intra-abdominal pressure measurement set mechanical :
Biofarma S.r.l.Via Castelliere 2

MERETO DI TOMBA
Udine 33036

Italy

Meditrial UK LtdUK Responsible Person10 Philpot Lane 1st Floor

London
EC 3M 8AA
UK Responsible Person
England United Kingdom
02/01/202221659
  • Stool softener oral :
Biofarma S.r.l.Via Castelliere 2

MERETO DI TOMBA
Udine 33036

Italy

Meditrial UK LtdUK Responsible Person10 Philpot Lane 1st Floor

London
EC 3M 8AA
UK Responsible Person
England United Kingdom
02/01/202221660
  • Stool softener oral :
BioFire Diagnostics LLC515 Colorow Drive Salt Lake City

Utah
Salt Lake City UT84108

United States

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA
UK Responsible Person
England United Kingdom
04/08/202113189
  • Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid amplification/mass spectrometry :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Multiple-type osteoarticular pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
Biofrontera Pharma GmbHHemmelrather Weg 201

Leverkusen
51377

Germany

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/17/202221269
  • Skin photodynamic therapy lamp :
Biofrost Viking Lab Oy LtdRovaniementie 305

Ivalo
99800

Finland

Win Health Medical LtdUK Responsible PersonUnit 1 Oxnam Road Industrial Estate
Jedburgh
Jedburgh
TD8 6LS
UK Responsible Person
United Kingdom
04/14/202221268
  • Hot/cold therapy pack reusable :
Biogen MA Inc.225 Binney Street

Cambridge
MA MA 02142

United States

Biogen Idec LimitedUK Responsible PersonInnovation House 70 Norden Rd

Maidenhead
Berkshire SL64AY
UK Responsible Person
England United Kingdom
06/21/202225004
  • Syringe plunger stop :
BioGend Therapeutics Co Ltd4F No 3-2 Park Street

Taipei City
Nangang District 115

Taiwan

henry.liu@biogend.com.tw
Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202215142
  • Pulsed signal therapy system extremity coil :
Biogroup laboratory limited21 evesham street The studio building
London
London
W11 4AJ

England United Kingdom







06/09/202224916
  • Home blood collection kit IVD :
  • ,
  • Oral/upper respiratory tract specimen collection kit IVD home-use :
  • ,
  • Faecal specimen collection kit IVD home-use :
  • ,
  • General specimen collection kit IVD home-use :
Biohit OYJLaippatie 1

Helsinki
FI-00880

Finland

BIOHIT HealthCare LtdUK Responsible PersonPioneer House Pioneer Business Park
North Road
Ellesmere Port
Cheshire CH65 1AD
UK Responsible Person
England United Kingdom
06/22/202219851
  • Helicobacter pylori urease IVD kit chromogenic :
  • ,
  • Helicobacter pylori urease IVD control :
  • ,
  • Lactase IVD kit rapid ICT clinical :
  • ,
  • Lactase IVD control :
  • ,
  • Tissue transglutaminase antibody IVD kit rapid ICT clinical :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Specimen stabilization reagent IVD :
  • ,
  • Pepsinogen I IVD kit enzyme immunoassay (EIA) :
  • ,
  • Pepsinogen II IVD kit enzyme immunoassay (EIA) :
  • ,
  • Gastrin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Calprotectin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Faecal specimen container IVD transport buffer/medium :
  • ,
  • Vitamin B12 IVD reagent :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Faecal occult blood IVD control :
  • ,
  • Enzyme immunoassay (EIA) analyser IVD semi-automated :
  • ,
  • Oral acetaldehyde inactivator :
  • ,
  • Multiple gastrointestinal disease marker IVD kit enzyme immunoassay (EIA) :
BioHorizons Implant Systems Inc.2300 Riverchase Center

Birmingham Alabama
35244

United States

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
05/27/202010070
  • Membrane fixation tack non-bioabsorbable :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Bone tack inserter basic :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Bone tap single-use sterile :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Diamond dental bur reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Carbide dental bur reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental instrument depth limiter :
  • ,
  • Dental precision attachment fitting/adjustment tool :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Instrument tray reusable :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Manual non-rotary dental instrument handle :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Bone tack inserter basic :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Dental osteotome :
  • ,
  • Dental implantation drilling template guide-sleeve :
BioHorizons Implant Systems Inc2300 Riverchase Center

Birmingham
Alabama 35244

United States

BioHorizons UK LtdUK Responsible PersonRichmond House Oldbury Road

Bracknell
Berkshire RG12 8TQ
UK Responsible Person
England United Kingdom
09/02/202117230
  • Dental amalgam condenser reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • General-purpose surgical spatula :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Centrifuge bucket/tube holder :
  • ,
  • Steel dental bur reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Electrical mains power cable :
  • ,
  • Haematological concentrate system :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental power tool converter attachment rotary :
  • ,
  • Centrifuge rotor ultracentrifuge :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • Resilient dental precision attachment :
  • ,
  • General-purpose bowl reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Haematological concentrate system :
  • ,
  • Haematological concentrate system :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental prosthesis/implant abutment screw analog reusable :
  • ,
  • Dental precision attachment fitting/adjustment tool :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental instrument depth limiter :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Manual non-rotary dental instrument handle :
BioIntegral Surgical1-200 Britannia Rd E Unit 1

MISSISSAUGA
L4Z 1S6

Canada

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/30/202114216
  • Aortic heart valve bioprosthesis :
  • ,
  • Pulmonary heart valve bioprosthesis :
  • ,
  • Cardiovascular patch animal-derived :
  • ,
  • Vascular xenograft :
BIOKIT S.A.Av. Can Montcau 7 08186 Lliçà d'Amunt Barcelona

Barcelona
08186

Spain

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202217511
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit agglutination :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagent :
  • ,
  • Rheumatoid factor IVD kit agglutination :
  • ,
  • Coagulation factor X IVD control :
  • ,
  • von Willebrand factor: collagen binding activity (vWF:CBA) IVD reagent :
  • ,
  • Platelet factor 4 IVD kit enzyme immunoassay (EIA) :
  • ,
  • Fibrinogen degradation product (FDP) IVD calibrator :
  • ,
  • Fibrinogen degradation product (FDP) IVD control :
  • ,
  • Fibrinogen degradation product (FDP) IVD kit agglutination :
  • ,
  • Chemiluminescent immunoassay analyser IVD automated :
  • ,
  • Buffered wash solution IVD manual :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Plasma protein IVD calibrator :
  • ,
  • Plasma protein IVD control :
  • ,
  • Beta-2-microglobulin IVD calibrator :
  • ,
  • Digitoxin therapeutic drug monitoring IVD control :
  • ,
  • Lipoprotein A IVD calibrator :
  • ,
  • Lipoprotein A IVD control :
  • ,
  • Myoglobin IVD calibrator :
  • ,
  • Ferritin IVD calibrator :
  • ,
  • Rheumatoid factor IVD calibrator :
  • ,
  • D-dimer IVD kit agglutination :
  • ,
  • D-dimer IVD control :
  • ,
  • D-dimer IVD calibrator :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibrator :
  • ,
  • Lipoprotein A IVD kit nephelometry/turbidimetry :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetry :
  • ,
  • Alpha-1-acid glycoprotein (orosomucoid) IVD kit nephelometry/turbidimetry :
  • ,
  • Ferritin IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin E (IgE total) IVD calibrator :
  • ,
  • Beta-2-microglobulin IVD kit nephelometry/turbidimetry :
  • ,
  • Rheumatoid factor IVD kit nephelometry/turbidimetry :
  • ,
  • Digitoxin therapeutic drug monitoring IVD calibrator :
  • ,
  • Myoglobin IVD kit nephelometry/turbidimetry :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit nephelometry/turbidimetry :
  • ,
  • Digitoxin therapeutic drug monitoring IVD kit nephelometry/turbidimetry :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD kit nephelometry/turbidimetry :
  • ,
  • Culture tube :
  • ,
  • C-reactive protein (CRP) IVD kit nephelometry/turbidimetry :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Instrument/analyser test tube rack adaptor IVD :
  • ,
  • Instrument/analyser specimen/reagent container carrier IVD :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • General laboratory container single-use :
  • ,
  • Test tube/reservoir cap :
  • ,
  • Laboratory instrument/analyser rinse fluid tank IVD :
  • ,
  • Chemiluminescent immunoassay analyser IVD automated :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Instrument/analyser test tube rack adaptor IVD :
  • ,
  • Instrument/analyser specimen/reagent container carrier IVD :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Test tube/reservoir cap :
  • ,
  • General laboratory container single-use :
Biokosmes S.r.l.Via Besana 10

Milan
20122

Italy

Venture Life HealthcareUK Responsible Person12 The Courtyard
Eastern Rd
BERKSHIRE
BRACKNELL RG12 2XB
UK Responsible Person
England United Kingdom
03/21/202223716
  • Anorectal lubrication dressing :
  • ,
  • Skin moisture barrier dressing :
BioLegend Inc.8999 Biolegend Way

San Diego
California 92121

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/08/202119615
  • D2-40 antigen IVD kit enzyme immunohistochemistry :
  • ,
  • Gross cystic disease fluid protein-15 IVD kit enzyme immunohistochemistry :
  • ,
  • Immunohistochemistry antibody detection IVD kit enzyme immunohistochemistry :
Biolife LLC8163 25th Court East

Sarasota
Florida 34243

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
08/25/202117067
  • Non-organic haemostatic agent :
Bioline Products s.r.o.Krakovska 1338/10
Krakovská Praha 1
Praha
Hlavní msto Praha 110 00

Czechia

Enteromed LtdUK Responsible Person85 Great Portland Street First Floor

London
W1W 7LT
UK Responsible Person
England United Kingdom
11/10/202118275
  • Mineral-based gastrointestinal detoxifier :
Biolog-id1 rue du Commandant Robert Malrait

ZA des Granges Bernay
27303

France

Easy Medical Device LimitedUK Responsible Person125 Deansgate

Manchester
M3 2LH
UK Responsible Person
Wales United Kingdom
11/08/202119447
  • Blood bank information system :
Biolux Technology GmbHNeubaugasse 31

Absdorf
3462

Austria

FREYR LIFE SCIENCES LTDUK Responsible Person9 Greyfriars Road

Reading
Berkshire RG1 1NU
UK Responsible Person
England United Kingdom
UKRP@FREYRSOLUTIONS.COM
02/01/202222067
  • Red-light phototherapy unit :
bioLytical Laboratories Inc.406-13251 Delf Place

Richmond
British Columbia V6V 2A2

Canada

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
04/21/202113307
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD control :
  • ,
  • SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 total antibody IVD control :
  • ,
  • HIV1/HIV2 antibody IVD control :
  • ,
  • HIV1/HIV2/Treponema pallidum antibody IVD kit rapid ICT clinical :
  • ,
  • HIV1/HIV2 antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test :
  • ,
  • Hepatitis C virus total antibody IVD kit rapid ICT clinical :
  • ,
  • Hepatitis C virus total antibody IVD control :
BIOMAG MedicalKarel Hrní – Biomag Chomutice 81

Chomutice
507 53

Czechia

NewMed LtdUK Responsible PersonStation Yard Station Road
Harrietsham Maidstone
Maidstone
Kent ME17 1JA
UK Responsible Person
England United Kingdom
04/26/202224369
  • Deep-tissue electromagnetic stimulation system home-use :
Biomate Medical Devices Technology Co. Ltd.1F No. 59 Luke 2nd Rd. Luzhu Dist.

Kaohsiung City
821

Taiwan

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
08/02/202225471
  • Dental implant system :
BioMaterials Korea Inc#329 #331 #413 150 Jojeong-daero

Hanam-si
Gyeonggi-do 12930

South Korea

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

London
W1H 1PJ
UK Responsible Person
United Kingdom
02/03/202222655
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Craniofacial fixation plate non-bioabsorbable :
  • ,
  • Screwing power tool attachment :
  • ,
  • Fluted surgical drill bit reusable :
Biomatlante SAZA les Quatre Nations 5 Rue Edouard Belin

Vigneux de Bretagne
44360

France

Advanced Medical Solutions LtdUK Responsible PersonPremier Park 33 Road One
Winsford Industrial Estate
Winsford
Cheshire CW7 3RT
UK Responsible Person
United Kingdom
04/12/202113288
  • Orthopaedic bone screw bioabsorbable :
  • ,
  • Bone matrix implant synthetic non-antimicrobial :
  • ,
  • General oral wound dressing animal-derived : General oral wound dressing animal-derived Conformity Assessment Certificate Expired
BIOMEC SRLVIA NAZIONALE NORD 21/A

COLICO (LC)
23823

Italy

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202218860
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
BioMedica Diagnostics Inc94 Wentworth Road PO Box 1030

Windsor
Nova Scotia B0N 2T0

Canada

Invitech LtdUK Responsible PersonUnit 4 Molesworth Business Estate Molesworth

Huntingdon
Cambs PE28 0QG
UK Responsible Person
United Kingdom
11/10/202119295
  • Lupus anticoagulant marker IVD kit clotting :
  • ,
  • Lupus anticoagulant marker IVD control :
  • ,
  • D-dimer IVD kit agglutination :
Biomedica Medizinprodukte GmbHDivischgasse 4

Vienna
1210

Austria

Oxford Biosystems LtdUK Responsible Person184B Park Drive Milton Park
Abingdon
Abingdon
Oxfordshire OX14 4SE
UK Responsible Person
United Kingdom
04/26/202221647
  • Complement component C4d IVD antibody :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit enzyme immunoassay (EIA) :
  • ,
  • Oxidized low density lipoprotein (OxLDL) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Osteoprotegerin/osteoclastogenesis inhibitory factor (OCIF) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Soluble tumour necrosis factor receptor 1 (sTNFR1) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Intact fibroblast growth factor 23 (iFGF23) IVD kit chemiluminescent immunoassay :
  • ,
  • Atrial natriuretic peptide (ANP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Lipid peroxide IVD kit enzyme spectrophotometry :
Biomedica su Misura SRLVia Rieti 8

Brescia
25125

Italy

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

Wellingborough
Northants NN8 6XF
UK Responsible Person
England United Kingdom
enquiries@kinetecuk.com
04/13/202221186
  • Orthotic shoe non-customized :
Biomedical Data Solutions LimitedCentrum Point Third Avenue
Centrum 100
Burton Upon Trent
Staffordshire DE14 2WD

United Kingdom







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

ALICANTE
VILLENA 3400

Spain

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
09/03/202117288
  • Orthotic shoe non-customized :
bioMerieux Inc100 Rodolphe Street

Durham
NC 27712

United States

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA
UK Responsible Person
England United Kingdom
04/08/202113190
  • Multiple anaerobic bacteria species culture isolate identification IVD kit :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD kit :
  • ,
  • Multiple gram negative bacteria species culture isolate identification IVD kit :
  • ,
  • Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD kit :
  • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
  • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
  • ,
  • Basic/simple nutrient broth culture medium IVD :
  • ,
  • Saline suspension medium/diluent IVD :
  • ,
  • Differential/selective broth culture medium IVD :
  • ,
  • Multiple Candida/yeast species culture isolate identification IVD kit :
  • ,
  • Basic/simple nutrient broth culture medium IVD :
  • ,
  • Blood culture analyser IVD automated :
  • ,
  • Microbial identification mass spectrometry system IVD :
  • ,
  • General-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Microorganism identification/antimicrobial-susceptibility analyser IVD semi-automated :
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France

bioMérieux UK LtdUK Responsible PersonChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA
UK Responsible Person
England United Kingdom
03/30/202113038
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1 antigen neutralization IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1 antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus e-antigen/antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antigen/antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin A (IgA)/IgG/IgM antibody IVD reagent :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD kit :
  • ,
  • Adenovirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human parechovirus (HPeV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple gram negative bacteria species culture isolate identification IVD kit :
  • ,
  • Parvovirus B19 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple anaerobic bacteria species culture isolate identification IVD reagent :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Indole/Kovac's microbial reagent IVD :
  • ,
  • Hepatitis A virus total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Enterovirus nucleic acid (serotypes 68-71) IVD kit nucleic acid technique (NAT) :
  • ,
  • Dengue virus antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus nucleic acid IVD control :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit enzyme immunoassay (EIA) :
  • ,
  • Protein C IVD kit fluorescent immunoassay :
  • ,
  • Antifungal minimum inhibitory concentration (MIC) IVD :
  • ,
  • Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple cardiac marker IVD kit enzyme immunoassay (EIA) :
  • ,
  • D-dimer IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Prolactin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Parathyroid hormone (PTH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free cortisol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Progesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Myoglobin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Beta-2-microglobulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Staphylococcus bacterial species culture isolate identification IVD kit :
  • ,
  • Legionella pneumophila nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Streptococcus bacterial species culture isolate identification IVD kit :
  • ,
  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD reagent :
  • ,
  • Helicobacter pylori transport medium IVD :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD :
  • ,
  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD sheep blood :
  • ,
  • Multiple acute kidney injury (AKI) marker IVD kit fluorescent immunoassay :
  • ,
  • Fastidious-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Free thyroxine (FT4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple thyroid antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Optical instrument performance standard calibrator/control IVD single-use :
  • ,
  • Thyroglobulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Free triiodothyronine (FT3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Digoxin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amies transport medium IVD :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total triiodothyronine (TT3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Basic/simple nutrient broth culture medium IVD :
  • ,
  • Pipette tip IVD :
  • ,
  • McFarland standard IVD :
  • ,
  • Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Interferon gamma release IVD control :
  • ,
  • Basic/simple nutrient agar culture medium IVD :
  • ,
  • Enriched broth culture medium IVD :
  • ,
  • Enriched agar culture medium IVD :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit fluorescent immunoassay :
  • ,
  • Multiple bacteria species culture isolate identification control IVD kit :
  • ,
  • Microscope slide stainer IVD :
  • ,
  • Nucleic acid sample preparation instrument IVD automated :
  • ,
  • Total thyroxine (TT4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Procalcitonin (PCT) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 125 (CA125) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD kit :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Bordetella pertussis nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Clostridium difficile antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD reagent :
  • ,
  • Catalase production microbial reagent IVD :
  • ,
  • Multiple Bordetella species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Clostridium difficile antigen IVD antibody :
  • ,
  • Tryptophan utilization/spot indole microbial reagent IVD :
  • ,
  • ONPG (ortho-nitrophenyl-beta-galactoside) differentiation disc IVD :
  • ,
  • Optochin/ethylhydrocupreine differentiation disc IVD :
  • ,
  • Troponin I IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple aerobic gram positive bacteria species culture isolate identification IVD kit :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Hepatitis E virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ferritin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Candida/yeast species culture isolate identification IVD kit :
  • ,
  • Coagulase production microbial reagent IVD :
  • ,
  • Indole broth/peptone water microbial reagent IVD :
  • ,
  • Oxidase production microbial reagent IVD :
  • ,
  • Differential/selective broth culture medium IVD :
  • ,
  • Pipette tip IVD :
  • ,
  • Multiple Neisseria species culture isolate identification IVD kit :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total immunoglobulin E (IgE total) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Nucleic acid technique (NAT) kit IVD :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit fluorescent immunoassay :
  • ,
  • Fluorescent immunoassay analyser IVD laboratory automated :
  • ,
  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Total prostate specific antigen (tPSA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Gram stain IVD reagent :
  • ,
  • Multiple Enterobacteriaceae species culture isolate identification IVD reagent :
  • ,
  • Multiple bacteria carbapenemase production IVD kit chromogenic :
  • ,
  • Differential/selective agar culture medium IVD :
  • ,
  • Nucleic acid sample preparation instrument IVD semi-automated :
  • ,
  • Human infectome analysis interpretive software IVD :
  • ,
  • Antimicrobial susceptibility strip dispenser IVD :
  • ,
  • Multiple formulation agar culture medium IVD :
  • ,
  • Fluorescent immunoassay analyser IVD laboratory semi-automated :
  • ,
  • Microbial identification mass spectrometry system IVD :
  • ,
  • General-microorganism antimicrobial susceptibility culture medium IVD :
  • ,
  • Nephelometry/turbidimetry analyser IVD manual :
  • ,
  • Saline suspension medium/diluent IVD :
  • ,
  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA) : Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA) Conformity Assessment Certificate Expired
  • ,
  • Antibacterial minimum inhibitory concentration (MIC) IVD :
  • ,
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Chikungunya virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Chikungunya virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD reagent :
  • ,
  • Interferon gamma release IVD kit enzyme immunoassay (EIA) :
Biomet 3i LLC4555 Riverside Dr

Palm Beach Gardens
Florida 33410

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
04/26/202113883
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Bone trephine :
  • ,
  • Bone tap reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental osteotome set :
  • ,
  • Dental osteotome :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Dental abrasive disk reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Instrument tray reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental osteotome set :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant analog :
  • ,
  • Dental torque wrench :
  • ,
  • Dental prosthesis/implant abutment screw analog reusable :
  • ,
  • Manual endodontic file/rasp reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
Biomet Biologics LLC56 East Bell Drive

Warsaw
Indiana IN 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
11/15/202118256
  • General oral wound dressing animal-derived :
  • ,
  • Haematological concentrate system delivery unit :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
  • ,
  • Orthopaedic trocar blade single-use :
  • ,
  • Haematological concentrate system :
  • ,
  • Centrifuge tube counterbalance :
  • ,
  • Surgical instrument handle non-torque-limiting :
Biomet France SARL58 Avenue de Lautagne BP 75 Cedex 9

Valence
26903

France

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
05/14/202114643
  • Orthopaedic cement non-antimicrobial :
  • ,
  • Orthopaedic cement dispenser :
  • ,
  • Orthopaedic cement compressor :
  • ,
  • Orthopaedic cement non-antimicrobial :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Orthopaedic cement spatula :
  • ,
  • Orthopaedic material preparation vacuum pump :
  • ,
  • Bone matrix implant animal-derived non-bioabsorbable :
  • ,
  • Manual orthopaedic cement mixer reusable :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Uncoated femoral stem prosthesis modular :
  • ,
  • Body femoral/tibial extension stem uncoated :
  • ,
  • Acetabular shell :
  • ,
  • Mobile-bearing total knee prosthesis :
  • ,
  • Coated hip femur prosthesis modular :
  • ,
  • Total shoulder prosthesis :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic cement antimicrobial :
  • ,
  • Orthopaedic cement dispenser :
  • ,
  • Orthopaedic cement dispenser :
Biomet Microfixation1520 Tradeport Drive

Jacksonville
Florida 32218

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
05/18/202114755
  • Bone matrix implant synthetic non-antimicrobial :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Cranioplasty plate screw :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Temporary mandibular condyle prosthesis :
  • ,
  • Orthopaedic bone washer non-sterile :
  • ,
  • Orthodontic wire :
  • ,
  • Bone tap reusable :
  • ,
  • Orthopaedic knife :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical power tool system handpiece rotary non-rechargeable battery-powered reusable :
  • ,
  • Iliofemoral vein stent :
  • ,
  • Screw extractor reusable :
  • ,
  • Endoscopic control/video-imaging system :
  • ,
  • Instrument tray reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Hand-held dental retractor :
  • ,
  • Surgical countersink reusable :
  • ,
  • General-purpose calliper metallic :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Hot/cold therapy pack single-use :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Medical ruler reusable :
  • ,
  • Bone holding forceps :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Orthopaedic fixation plate bending insert reusable :
  • ,
  • Orthopaedic fixation implant alignment tool :
  • ,
  • Disposable battery pack :
  • ,
  • Needle guide reusable :
  • ,
  • Funnel chest remodelling bar :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Bone-coring punch reusable :
  • ,
  • Surgical implant handling forceps :
  • ,
  • Orthopaedic implantable-device cutter :
  • ,
  • Orthopaedic implantable-device cutter :
  • ,
  • Wire cutter :
  • ,
  • Wire holding/twisting forceps :
  • ,
  • Orthodontic ligature director :
  • ,
  • Orthopaedic implantable-device cutter :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • General surgical procedure kit non-medicated single-use :
  • ,
  • Total temporomandibular joint prosthesis :
  • ,
  • Bone tap single-use non-sterile :
  • ,
  • Cranioplasty plate alterable :
  • ,
  • Craniofacial bone screw bioabsorbable :
  • ,
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Craniofacial fixation plate bioabsorbable :
  • ,
  • Craniofacial fixation plate non-bioabsorbable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Manual orthopaedic bender reusable :
  • ,
  • Funnel chest remodelling bar :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Cranioplasty sheet :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical implant template reusable :
  • ,
  • Sternal fixation device :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical instrument/implant rack :
  • ,
  • Total temporomandibular joint prosthesis :
  • ,
  • Cranial bur single-use :
  • ,
  • Cranioplasty plate alterable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical screwdriver reusable :
Biomet Orthopaedics LLC56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
05/28/202114983
  • Knee arthroplasty wedge :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Orthopaedic cement spacer mould :
  • ,
  • Acetabular shell :
  • ,
  • Reverse shoulder prosthesis base plate :
  • ,
  • Reverse shoulder prosthesis head :
  • ,
  • Acetabulum prosthesis hole plug :
  • ,
  • Femoral head/stem prosthesis adaptor :
  • ,
  • Reverse shoulder prosthesis body :
  • ,
  • Shoulder humeral body prosthesis :
  • ,
  • Humeral stem extension prosthesis :
  • ,
  • Femoral stem centralizer :
  • ,
  • Press-fit femoral stem prosthesis :
  • ,
  • Uncoated elbow humerus prosthesis :
  • ,
  • Partial shoulder prosthesis :
  • ,
  • Orthopaedic cement spacer :
  • ,
  • Uncoated femoral stem prosthesis one-piece :
  • ,
  • Uncoated hip femur prosthesis modular :
  • ,
  • Polyethylene reverse shoulder prosthesis cup :
  • ,
  • Polyethylene reverse shoulder prosthesis cup :
  • ,
  • Metallic acetabular liner :
  • ,
  • Stem-fixed humeral head prosthesis :
  • ,
  • Coated femoral stem prosthesis modular :
  • ,
  • Surgical saw blade sagittal single-use :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Manual bone mill :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Surgical saw blade reciprocating single-use :
  • ,
  • Surgical saw blade oscillating single-use :
  • ,
  • Surgical implant template reusable :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Orthopaedic implant/instrument adaptor single-use :
  • ,
  • Shoulder glenoid fossa prosthesis trial :
  • ,
  • Humeral stem prosthesis trial reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Wire cutter :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Manual surgical rotary handpiece reusable :
  • ,
  • Orthopaedic osteotome blade reusable :
  • ,
  • Mobile-bearing total ankle prosthesis :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Orthopaedic bone nut :
  • ,
  • Topical liquid dose dispenser :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Body femoral/tibial extension stem coated :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical tamp reusable :
  • ,
  • Orthopaedic chisel blade :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Orthopaedic osteotome blade reusable :
  • ,
  • Orthopaedic chisel :
  • ,
  • Surgical mallet :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Manual surgical saw rigid :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Sternal fixation device :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Orthopaedic implant aiming/guiding block reusable :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Knee femur prosthesis trial reusable :
  • ,
  • Knee tibia prosthesis trial reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder single-use :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Bone-coring punch reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Suturing unit reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Radiology DICOM image processing application software :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Coated knee tibia prosthesis :
  • ,
  • Orthopaedic osteotome blade reusable :
  • ,
  • Orthopaedic implant/instrument dismantling device :
  • ,
  • Humeral stem extension prosthesis :
  • ,
  • Tubular support bandage non-latex reusable :
  • ,
  • Screw extractor reusable :
  • ,
  • Cannulated surgical drill guiding pin :
  • ,
  • Surgical torque wrench adaptor :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Ankle prosthesis trial :
  • ,
  • Metacarpophalangeal joint prosthesis modular :
  • ,
  • Bone-resection orthopaedic reamer single-use :
  • ,
  • Acetabular augmentation implant :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Reverse shoulder cup prosthesis trial reusable :
  • ,
  • Sleeve femoral/tibial extension uncoated :
  • ,
  • Femur/tibia shaft prosthesis :
  • ,
  • Sleeve femoral/tibial extension coated :
  • ,
  • Femoral stem centralizer :
  • ,
  • Elbow radius prosthesis trial :
  • ,
  • Flexible bone nail non-sterile :
  • ,
  • Neurosurgical probe :
  • ,
  • Humeral stem extension prosthesis trial :
  • ,
  • Body femoral/tibial extension stem uncoated :
  • ,
  • Glenoid orthopaedic reamer :
  • ,
  • Reverse shoulder head prosthesis trial :
  • ,
  • Shoulder glenoid fossa prosthesis trial :
  • ,
  • Humeral body extension prosthesis :
  • ,
  • Humeral body extension prosthesis trial :
  • ,
  • Humeral body prosthesis trial :
  • ,
  • Humeral stem prosthesis trial reusable :
  • ,
  • Total knee prosthesis implantation guide-instrument kit :
  • ,
  • Metallic acetabulum prosthesis :
  • ,
  • Combination-material acetabulum prosthesis :
  • ,
  • Metallic reverse shoulder prosthesis cup :
  • ,
  • Shoulder humeral body prosthesis :
  • ,
  • Reverse shoulder prosthesis body :
  • ,
  • Arthrodesis nail non-sterile :
  • ,
  • Femoral head/stem prosthesis adaptor :
  • ,
  • Orthopaedic prosthesis implantation instrument single-use :
  • ,
  • Ceramic acetabulum prosthesis :
  • ,
  • Femoral head prosthesis trial :
  • ,
  • Surgical screwdriver single-use sterile :
  • ,
  • Elbow ulna prosthesis trial :
  • ,
  • Elbow humerus prosthesis trial :
  • ,
  • Knee tibia prosthesis trial reusable :
  • ,
  • Knee femur prosthesis trial reusable :
  • ,
  • Patella prosthesis trial :
  • ,
  • Femoral stem prosthesis trial :
  • ,
  • Acetabulum prosthesis trial prefabricated reusable :
  • ,
  • Humeral head prosthesis trial reusable :
  • ,
  • Coated ankle talus prosthesis :
  • ,
  • Patellofemoral joint prosthesis :
  • ,
  • Diaphysis prosthesis :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Acetabulum prosthesis hole plug :
  • ,
  • Bone tap single-use sterile :
  • ,
  • Tibia nail non-sterile :
  • ,
  • Humerus nail non-sterile :
  • ,
  • Femur nail non-sterile :
  • ,
  • Flexible bone nail sterile :
  • ,
  • Press-fit hip femur prosthesis one-piece :
  • ,
  • Press-fit hip femur prosthesis modular :
  • ,
  • Humeral head prosthesis trial single-use :
  • ,
  • Uncoated ankle talus prosthesis :
  • ,
  • Bicompartmental knee prosthesis :
  • ,
  • Unicondylar knee insert :
  • ,
  • Polyethylene elbow ulna prosthesis :
  • ,
  • Shoulder prosthesis screw :
  • ,
  • Reverse shoulder prosthesis head :
  • ,
  • Polyethylene reverse shoulder prosthesis cup :
  • ,
  • Reverse shoulder prosthesis base plate :
  • ,
  • Press-fit shoulder humeral stem prosthesis :
  • ,
  • Resurfacing humeral head prosthesis :
  • ,
  • Stem-fixed humeral head prosthesis :
  • ,
  • Ankle prosthesis bearing :
  • ,
  • Coated unicondylar knee tibia prosthesis :
  • ,
  • Knee femur stem prosthesis :
  • ,
  • Knee arthroplasty wedge :
  • ,
  • Uncoated unicondylar knee tibia prosthesis metallic :
  • ,
  • Uncoated unicondylar knee tibia prosthesis polyethylene :
  • ,
  • Medullary canal orthopaedic reamer rigid :
  • ,
  • Ulna nail non-sterile :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Orthopaedic implant aiming arm :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic fixation implant alignment tool :
  • ,
  • Orthopaedic ball spike :
  • ,
  • Bone-nailing spacer :
  • ,
  • External orthopaedic fixation system single-use :
  • ,
  • Orthopaedic bone-fragment manipulator single-use sterile :
  • ,
  • Ceramic acetabular liner :
  • ,
  • Metallic acetabular liner :
  • ,
  • Orthopaedic fixation plate tensioner :
  • ,
  • Surgical countersink single-use :
  • ,
  • Soft-tissue/mesh anchor non-bioabsorbable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Tibial insert :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate kit bioabsorbable :
  • ,
  • Orthopaedic fixation plate kit non-bioabsorbable non-antimicrobial :
  • ,
  • Clavicle fixation pin :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Bone tap single-use non-sterile :
  • ,
  • Ulna nail sterile :
  • ,
  • Revision coated femoral stem prosthesis :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Arthrodesis nail sterile :
  • ,
  • Orthopaedic implantable-device cutter :
  • ,
  • Manual orthopaedic bender reusable :
  • ,
  • Constrained polyethylene acetabular liner :
  • ,
  • Arthroscopic surgical procedure kit non-medicated single-use :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Acetabular shell :
  • ,
  • Metacarpal prosthesis :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • External orthopaedic fixation system reusable :
  • ,
  • Coated ankle tibia prosthesis :
  • ,
  • Coated shoulder humeral stem prosthesis :
  • ,
  • Ceramic femoral head prosthesis :
  • ,
  • Press-fit femoral stem prosthesis :
  • ,
  • Humerus nail sterile :
  • ,
  • Shoulder glenoid fossa prosthesis prefabricated :
  • ,
  • Orthopaedic broach :
  • ,
  • Total shoulder prosthesis :
  • ,
  • Hinged total elbow prosthesis :
  • ,
  • Polyethylene patella prosthesis :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Bone approximation clamp :
  • ,
  • Uncoated hip femur prosthesis one-piece :
  • ,
  • Coated unicondylar knee femur prosthesis :
  • ,
  • Ceramic-on-ceramic total hip prosthesis :
  • ,
  • Uncoated femoral stem prosthesis modular :
  • ,
  • Uncoated ankle tibia prosthesis :
  • ,
  • Bone clamp traction bar :
  • ,
  • Revision coated hip femur prosthesis :
  • ,
  • Revision uncoated femoral stem prosthesis :
  • ,
  • Polyethylene acetabulum prosthesis :
  • ,
  • Uncoated hip femur prosthesis modular :
  • ,
  • Coated femoral stem prosthesis modular :
  • ,
  • Metal-backed patella prosthesis :
  • ,
  • Unicondylar knee prosthesis :
  • ,
  • Uncoated shoulder humeral stem prosthesis :
  • ,
  • Coated knee tibia prosthesis :
  • ,
  • Uncoated femoral stem prosthesis one-piece :
  • ,
  • Hip internal fixation system :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Partial metatarsophalangeal joint prosthesis :
  • ,
  • Elbow radius prosthesis :
  • ,
  • Uncoated elbow humerus prosthesis :
  • ,
  • Total wrist prosthesis :
  • ,
  • Partial shoulder prosthesis :
  • ,
  • Total reverse shoulder prosthesis :
  • ,
  • Bipolar partial shoulder prosthesis :
  • ,
  • Ceramic-on-polyethylene total hip prosthesis :
  • ,
  • Resurfacing metallic hip prosthesis :
  • ,
  • Ceramic-on-metal total hip prosthesis :
  • ,
  • Coated knee femur prosthesis :
  • ,
  • Humeral centering sleeve :
  • ,
  • Trabeculated bicondylar knee femur prosthesis :
  • ,
  • Bipolar femoral head outer component hemiarthroplasty :
  • ,
  • Metal-on-metal total hip prosthesis :
  • ,
  • Revision uncoated hip femur prosthesis :
  • ,
  • Metal-on-polyethylene total hip prosthesis :
  • ,
  • Femur nail sterile :
  • ,
  • Total wrist radius prosthesis :
  • ,
  • Partial wrist prosthesis :
  • ,
  • Uncoated knee tibia prosthesis polyethylene :
  • ,
  • Coated hip femur prosthesis modular :
  • ,
  • Mobile-bearing total ankle prosthesis :
  • ,
  • Cruciate-retaining total knee prosthesis :
  • ,
  • Uncoated knee tibia/insert prosthesis :
  • ,
  • Trabeculated knee tibia/insert prosthesis :
  • ,
  • Coated knee tibia/insert prosthesis :
  • ,
  • Rotating hinged total knee prosthesis :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Fixed-bearing total ankle prosthesis :
  • ,
  • Metal-backed elbow ulna prosthesis :
  • ,
  • Hip prosthesis socket pusher :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Acetabular orthopaedic reamer :
  • ,
  • Mobile-bearing total knee prosthesis :
  • ,
  • Uncoated knee tibia prosthesis metallic :
  • ,
  • Uncoated knee femur prosthesis metallic :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Manual bone mill :
  • ,
  • Orthopaedic bone bolt :
  • ,
  • Bone trephine :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Cannulated surgical drill bit reusable :
  • ,
  • Bone cutter :
  • ,
  • Coated elbow humerus prosthesis :
  • ,
  • Haematological concentrate system :
  • ,
  • Acetabulum prosthesis trial prefabricated reusable :
  • ,
  • Bipolar femoral head outer component hemiarthroplasty :
  • ,
  • Instrument tray reusable :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Uncoated unicondylar knee femur prosthesis :
  • ,
  • Uncoated knee femur prosthesis metallic :
  • ,
  • Uncoated knee tibia prosthesis metallic :
  • ,
  • Uncoated knee tibia prosthesis metallic :
  • ,
  • Coated hip femur prosthesis modular :
  • ,
  • Posterior-stabilized total knee prosthesis :
  • ,
  • Uncoated knee tibia/insert prosthesis :
  • ,
  • Humeral centering sleeve :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Coated knee femur prosthesis :
  • ,
  • Coated femoral stem prosthesis modular :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Polyethylene patella prosthesis :
  • ,
  • Coated shoulder humeral stem prosthesis :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Constrained polyethylene acetabular liner :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Tibial insert :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Knee femur stem prosthesis :
  • ,
  • Knee arthroplasty wedge :
  • ,
  • Uncoated unicondylar knee tibia prosthesis metallic :
  • ,
  • Unicondylar knee insert :
  • ,
  • Shoulder prosthesis screw :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Femoral head prosthesis trial :
  • ,
  • Femoral stem prosthesis trial :
  • ,
  • Patella prosthesis trial :
  • ,
  • Knee femur prosthesis trial reusable :
  • ,
  • Knee tibia prosthesis trial reusable :
  • ,
  • Elbow humerus prosthesis trial :
  • ,
  • Humeral head prosthesis trial reusable :
  • ,
  • Elbow radius prosthesis trial :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Coated hip femur prosthesis modular :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Acetabular shell :
Biomet Spain Orthopaedics SLCalle Islas Baleares 50 Fuente del Jarro

Valencia
46988

Spain

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
05/14/202114672
  • Uncoated knee tibia prosthesis metallic :
Biomet Sports Medicine56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
04/26/202113921
  • Soft-tissue/mesh anchor non-bioabsorbable :
  • ,
  • Ligament reconstruction instrument set reusable :
  • ,
  • Suturing unit single-use :
  • ,
  • Orthopaedic bone nut :
  • ,
  • Knee femur stem prosthesis :
  • ,
  • Sleeve femoral/tibial extension uncoated :
  • ,
  • Cannulated surgical drill bit reusable :
  • ,
  • Operative-site suture holder :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • General surgical procedure kit non-medicated single-use :
  • ,
  • Surgical drill guide obturator :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Suturing unit reusable :
  • ,
  • Arthroscopic surgical procedure kit non-medicated single-use :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Ligament reconstruction instrument set reusable :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Arthroscopic access cannula single-use :
  • ,
  • Suturing needle single-use :
  • ,
  • Bone awl reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Suturing unit single-use :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Suture cutter reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Orthopaedic knife :
  • ,
  • Orthopaedic bone screw starter/notcher :
  • ,
  • Orthopaedic wire crimper :
  • ,
  • Bone hook :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide obturator :
  • ,
  • Surgical gouge :
  • ,
  • Tendon stripper :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • External orthopaedic fixation system reusable :
  • ,
  • Arthroscopic probe :
  • ,
  • Manual surgical rotary handpiece reusable :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Orthopaedic graft inserter :
  • ,
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Ligament reconstruction instrument set reusable :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Orthopaedic implant aiming arm :
  • ,
  • Orthopaedic feeler :
  • ,
  • Bone awl reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Humeral centering sleeve :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Hard-tissue ultrasonic surgical system handpiece tip :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Orthopaedic bone screw bioabsorbable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Bone-resection orthopaedic reamer single-use :
Biomet Trauma56 East Bell Drive

Warsaw
Indiana 46582

United States

Zimmer Biomet UK LimitedUK Responsible PersonStella Building Windmill Hill Business Park
Whitehill Way
Swindon
Swindon SN5 6NX
UK Responsible Person
England United Kingdom
04/26/202113878
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Humerus nail sterile :
  • ,
  • Orthopaedic bone washer sterile :
  • ,
  • Bone-screw internal spinal fixation system non-sterile :
  • ,
  • Orthopaedic bone washer non-sterile :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Cannulated surgical drill bit reusable :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Surgical drill chuck :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Manual orthopaedic bender reusable :
  • ,
  • Surgical screwdriver single-use non-sterile :
  • ,
  • Surgical countersink single-use :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Bone tap single-use sterile :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Orthopaedic implantation sleeve single-use :
  • ,
  • Surgical screwdriver single-use sterile :
  • ,
  • Surgical implant template single-use :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Biopsy drill bit :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Bone hook :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Manual wire driver :
  • ,
  • Medullary canal orthopaedic reamer rigid :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Bone nail guidewire reusable :
  • ,
  • Bone holding forceps :
  • ,
  • Surgical screwdriver single-use non-sterile :
  • ,
  • Orthopaedic fixation plate tensioner :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical instrument handle torque-limiting :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Bone approximation clamp :
  • ,
  • Medical ruler reusable :
  • ,
  • Surgical mallet :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Instrument tray reusable :
  • ,
  • Orthopaedic implant driver :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Femur nail sterile :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Tibia nail sterile :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Manual orthopaedic bender reusable :
  • ,
  • Medullary canal orthopaedic reamer rigid :
  • ,
  • Surgical implant template reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Ultrasonic surgical system adaptor single-use :
  • ,
  • Bone tap single-use non-sterile :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Orthopaedic implant aiming arm :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Femur nail non-sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Bone nail end-cap :
Biomet UK LimitedWaterton Industrial Estate

Bridgend
CF31 3XA

Wales United Kingdom







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

Newport
NP11 7HZ

United Kingdom







04/10/20226924
  • Back/leg/chest dynamometer electronic :
  • ,
  • Biomechanical function analysis/interactive rehabilitation system :
  • ,
  • Biomechanical function analysis/rehabilitation software :
  • ,
  • Electromyograph :
  • ,
  • Electromyography telemetric monitoring system transmitter :
  • ,
  • Electronic goniometer/kinesiology sensor :
  • ,
  • Hand dynamometer/pinchmeter electronic :
  • ,
  • Posturography system :
  • ,
  • Posturography system platform :
  • ,
  • Electronic torsional hand exerciser :
  • ,
  • Kinesiology/electromyographic sensor set :
  • ,
  • Medical networking interface unit :
Biometrix Ltd4 Kiryat Mada

Jerusalem
9145000

Israel

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
06/28/202225078
  • Thoracic suction collection container :
  • ,
  • In-line arterial blood sampling set :
  • ,
  • Pleural catheter :
Biometrix s.r.oVicenzy 16

Samorin
93101

Slovakia

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
05/19/202224695
  • Closed-wound drainage kit :
BioMin Technologies LtdE204 Queens Building QMUL
Mile End
London
E1 4NS

England United Kingdom
00442032817282
info@biomin.co.uk






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

POOLE
Dorset BH12 4NQ

England United Kingdom







03/20/202212794
  • Nasal irrigation saline solution :
  • ,
  • Eyelid solution :
  • ,
  • Nail fungus treatment kit medicated :
  • ,
  • Superficial skin exfoliant home-use :
Bioncise NVBodemstraat 16

Wellen
3830

Belgium

ALS International Ltd Trading as I3CGLOBAL(UK)UK Responsible PersonOffice 54 58 Peregrine Road
Hainault
Ilford
Essex IG6 3SZ
UK Responsible Person
England United Kingdom
04/15/202223043
  • Soft-tissue biopsy procedure kit non-medicated :
BIONEER Corporation8-11 Munpyeongseo-ro

Daedeok-gu
Daejeon 34302

South Korea

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
01/18/202213753
  • HIV1 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Nucleic acid sample preparation instrument IVD automated :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
Bioner S.A.CALLE ESPIGOLERA 9

SANT JUST DESVERN (BARCELONA)
08960

Spain

Regen Marketing LimitedUK Responsible PersonIvy Cottage Bridgnorth Road
Stourton
Stourbridge
DY75BH
UK Responsible Person
England United Kingdom
01/24/202221990
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental drill bit extension :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Transgingival implant :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental instrument depth limiter :
  • ,
  • Dental torque wrench :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Manual non-rotary dental instrument handle :
  • ,
  • Membrane fixation tack non-bioabsorbable :
  • ,
  • Dental implant abutment impression cap :
  • ,
  • Dental prosthesis/implant abutment screw analog single-use :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Dental implant extractor :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
Bioness25103 Rye Canyon Loop

Valencia
CA 91355

United States

P14 Medical LtdUK Responsible Person65 Bath Road

Stroud
Gloucestershire GL5 3LA
UK Responsible Person
England United Kingdom
01/08/202111430
  • Analgesic implantable peripheral nerve electrical stimulation system :
  • ,
  • Tibial nerve implantable incontinence-control electrical stimulation system :
  • ,
  • Analgesic implantable peripheral nerve electrical stimulation system : Analgesic implantable peripheral nerve electrical stimulation system Conformity Assessment Certificate Expired
  • ,
  • Analgesic implantable peripheral nerve electrical stimulation system : Analgesic implantable peripheral nerve electrical stimulation system Conformity Assessment Certificate Expired
  • ,
  • Tibial nerve implantable incontinence-control electrical stimulation system : Tibial nerve implantable incontinence-control electrical stimulation system Conformity Assessment Certificate Expired
  • ,
  • Tibial nerve implantable incontinence-control electrical stimulation system : Tibial nerve implantable incontinence-control electrical stimulation system Conformity Assessment Certificate Expired
Bionic Medizintechnik GmbHMax-Planck-Strasse 21

Friedrichsdorf
61381

Germany

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
03/16/202216042
  • Haemodialysis needle :
  • ,
  • Haemodialysis chair electric :
  • ,
  • General examination/treatment chair electric :
Bionime Corporation100 Sec. 2 Daqing St. South Dist.

Taichung City
40242

Taiwan

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/01/202221656
  • Glucose monitoring system IVD home-use :
Bionix LLC1670 Indian Wood Circle

Maumee
Ohio 43537

United States

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
01/24/202222131
  • Enteral feeding tube clearing kit :
  • ,
  • General-purpose bowl reusable :
  • ,
  • ENT illuminating foreign body extraction set :
  • ,
  • Nasal speculum single-use :
  • ,
  • Endaural wax extraction curette :
  • ,
  • ENT instrument light source :
  • ,
  • ENT instrument magnifying lens :
  • ,
  • Ear canal irrigation kit reusable :
  • ,
  • Ear canal irrigation tip :
Bionnovation Produtos Biomédicos LtdRua Laureano Garcia 1-275 Distrito Industrial II

Bauru
17039-760

Brazil

Regen Marketing LimitedUK Responsible PersonIvy Cottage Bridgnorth Road
Stourton
Stourbridge
DY75BH
UK Responsible Person
England United Kingdom
05/19/202224703
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Extra-gynaecological surgical mesh metal :
  • ,
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Extra-gynaecological surgical mesh metal :
  • ,
  • General internal orthopaedic fixation system implantation kit :
Bionostics Inc7 Jackson Road

Devens
Massachusetts 01434

United States

Werfen LtdUK Responsible Person712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE
UK Responsible Person
England United Kingdom
04/13/202221700
  • Multiple haemoximetry analyte IVD control :
Bionote Inc.22 Samsung 1-ro 4-gil

Hwaseong-si
Gyeonggi-do 18449

South Korea

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
06/22/202115246
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD control :
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom







03/02/20209656
  • Adenovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD reagent :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit rapid ICT clinical :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD kit rapid ICT clinical :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit rapid ICT clinical :
  • ,
  • Cancer antigen 125 (CA125) IVD kit rapid ICT clinical :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit rapid ICT clinical :
  • ,
  • C-reactive protein (CRP) IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group B Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit fluorescent immunoassay :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassay :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassay :
  • ,
  • Calprotectin IVD kit rapid ICT clinical :
  • ,
  • Chikungunya virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical :
  • ,
  • Clostridium tetani immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit rapid ICT clinical :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinical :
  • ,
  • D-dimer IVD kit rapid ICT clinical :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit fluorescent immunoassay :
  • ,
  • Cystatin C IVD reagent :
  • ,
  • D-dimer IVD kit fluorescent immunoassay :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassay :
  • ,
  • Dengue virus antigen IVD reagent :
  • ,
  • Dengue virus antigen/antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Clostridium difficile antigen IVD kit rapid ICT clinical :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Fluorescent immunoassay analyser IVD point-of-care battery-powered :
  • ,
  • Fatty acid binding protein (FABP) IVD reagent :
  • ,
  • Fatty acid binding protein (FABP) IVD reagent :
  • ,
  • Ferritin IVD kit rapid ICT self-testing :
  • ,
  • Giardia lamblia antigen IVD kit rapid ICT clinical :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit immunochromatographic test (ICT) rapid professional/self-test :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD kit rapid ICT clinical :
  • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
  • ,
  • Myoglobin IVD kit rapid ICT clinical :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD reagent :
  • ,
  • Leishmania donovani immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Norovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD reagent :
  • ,
  • Multiple helminth immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Legionella pneumophila antigen IVD kit rapid ICT clinical :
  • ,
  • Microalbumin IVD kit rapid ICT clinical :
  • ,
  • Plasmodium malariae antigen IVD kit rapid ICT clinical :
  • ,
  • Plasmodium vivax antigen IVD kit rapid ICT clinical :
  • ,
  • Neisseria gonorrhoeae antigen IVD kit rapid ICT clinical :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) rapid :
  • ,
  • Hepatitis E virus total antibody IVD reagent :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Glycated haemoglobin (HbA1C) analyser IVD :
  • ,
  • Myoglobin IVD kit fluorescent immunoassay :
  • ,
  • Microalbumin IVD reagent :
  • ,
  • Helicobacter pylori IgG antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Plasmodium falciparum antigen IVD kit rapid ICT clinical :
  • ,
  • Mycoplasma pneumoniae IgM antibody IVD kit immunochromatographic test (ICT) rapid professional/self-test :
  • ,
  • Interferon gamma release IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
  • ,
  • Streptococcus pneumoniae antigen IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit rapid ICT self-testing :
  • ,
  • Sperm concentration indicator IVD kit rapid ICT self-testing :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical :
  • ,
  • Rotavirus antigen IVD kit rapid ICT clinical :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Total haemoglobin (totHb) IVD reagent :
  • ,
  • Serum amyloid A IVD reagent :
  • ,
  • Procalcitonin (PCT) IVD kit rapid ICT clinical :
  • ,
  • Rheumatoid factor IVD reagent :
  • ,
  • Salmonella typhi antigen IVD kit rapid ICT clinical :
  • ,
  • Salmonella typhi immunoglobulin G (IgG)/IgM antibody IVD reagent :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassay :
  • ,
  • Procalcitonin (PCT) IVD kit fluorescent immunoassay :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Troponin I IVD kit fluorescent immunoassay :
  • ,
  • Troponin I IVD kit rapid ICT clinical :
  • ,
  • Troponin I IVD kit rapid ICT clinical :
  • ,
  • Troponin T IVD kit rapid ICT clinical :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Yersinia pseudotuberculosis total antibody IVD reagent :
  • ,
  • Urine bilirubin IVD kit colorimetric dipstick rapid :
  • ,
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT self-testing :
  • ,
  • Adenovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Multiple Brucella species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Campylobacter species antigen IVD kit rapid ICT clinical :
  • ,
  • Human astrovirus antigen IVD kit rapid ICT clinical :
  • ,
  • C-reactive protein (CRP) IVD kit rapid ICT clinical :
  • ,
  • Cryptococcus complex species antigen IVD kit rapid ICT clinical :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Cryptosporidium species antigen IVD kit rapid ICT clinical :
  • ,
  • Entamoeba histolytica antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Mycoplasma pneumoniae antigen IVD kit rapid ICT clinical :
  • ,
  • Norovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Salmonella paratyphi antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Salmonella species antigen IVD kit rapid ICT clinical :
  • ,
  • Streptococcus pneumoniae antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
BioPhotas Inc.1000 E. Howell Ave.

Anaheim
California 92805

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
01/24/202222086
  • Blue/red/infrared phototherapy lamp :
Bioplus co.Ltd#211 Migun Techno World 2 187 Techno 2-ro
Yuseong-gu
Daejeon
34025

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
04/20/202214682
  • Surgical anti-adhesion material implantable bioabsorbable :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
BioPolymer GmH & Co. KGWalsmuhler Strasse 18

Dummer
D-19073

Germany

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/08/202114480
  • Dermal tissue reconstructive material microbe-derived anaesthetic :
  • ,
  • Synovial fluid supplementation medium :
BioPro Inc2929 Lapeer Rd

Port Huron
Michigan 48060

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/13/202221231
  • Instrument tray reusable :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Orthopaedic osteotome blade single-use :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Subtalar implant non-bioabsorbable sterile :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Memory-alloy orthopaedic fixation plate :
  • ,
  • Partial metatarsophalangeal joint prosthesis :
  • ,
  • Intraoperative bone pin/screw sterile :
BioProtect Limited8 Tsor Street

Tzur Yigal
4486200

Israel

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
04/15/202113376
  • Radiotherapy protection spacer :
BiopSafe ApSCarolinevej 2A

Hellerup
2900

Denmark

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH
UK Responsible Person
England United Kingdom
01/14/202221274
  • General tissue specimen container IVD no additive :
Biopsybell S.R.LVia Aldo Manuzio n. 24

Mirandola
MO 41037

Italy

QCS International LTD.UK Responsible PersonSuite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ
UK Responsible Person
Scotland United Kingdom
05/19/202114792
  • Vertebral bone biopsy procedure kit single-use :
  • ,
  • Inflatable bone tamp :
  • ,
  • Vertebral body cement cannula :
  • ,
  • Percussion hammer manual :
  • ,
  • Bone graft syringe single-use :
  • ,
  • Balloon kyphoplasty kit :
  • ,
  • Stromal vascular fraction recovery set :
  • ,
  • Bone marrow explant needle :
  • ,
  • Bone access channel kit :
  • ,
  • Orthopaedic cement preparation/delivery kit :
Bioptimal International PTE. LTD.36 Jalan Tukang

Singapore
S(619266)

Singapore

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

London
W1H 1PJ
UK Responsible Person
United Kingdom
04/11/202224139
  • Angiography kit :
  • ,
  • Thrombectomy balloon catheter :
  • ,
  • Arterial/central venous catheterization support/maintenance kit non-medicated :
  • ,
  • Pulmonary artery balloon catheter thermal dilution :
  • ,
  • Temporary cardiac pacing balloon catheter :
  • ,
  • Pulmonary artery balloon catheter standard :
  • ,
  • Invasive-pressure external transducer single-use :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Indwelling urethral drainage balloon catheter non-antimicrobial :
  • ,
  • Vascular catheter introduction set nonimplantable :
Biorad Medisys Pvt LtdSurvey No.: 48/3 &48/7 Pashan Sus Road Sus Village Taluka Mulshi Pune - 411021 Maharashtra INDIA

Pune
Maharashtra 411021

India

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

London
W1H 1PJ
UK Responsible Person
United Kingdom
11/05/202119786
  • Assisted reproduction transfer catheter/set :
  • ,
  • Nephrostomy catheter :
  • ,
  • Suprapubic drainage catheter :
  • ,
  • Ureteral catheter :
  • ,
  • Endoscopic-access dilator single-use :
  • ,
  • Fascial tissue dilator single-use :
  • ,
  • Polymeric ureteral stent :
  • ,
  • Gastro-urological guidewire single-use :
  • ,
  • Nephrostomy catheter introduction needle :
  • ,
  • Body aspiration needle single-use :
  • ,
  • Biliary/urinary stone retrieval basket single-use :
  • ,
  • Luer/Luer linear connector single-use :
  • ,
  • Incontinence penis clamp single-use :
  • ,
  • Bladder evacuator single-use :
  • ,
  • Endoscopic electrosurgical electrode bipolar single-use :
  • ,
  • Endoscopic electrosurgical electrode monopolar single-use :
BioRegen Biomedical (Changzhou) Co. Ltd.Building B No. 117 Xueye Road

Changzhou
Jiangsu 213125

China

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

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202218586
  • Suction/irrigation tubing single-use :
  • ,
  • Wound hydrogel dressing non-antimicrobial :
  • ,
  • Wound hydrogel dressing non-antimicrobial :
Bioretec LtdYrittajankulma 5 FL-33710 Tamperer

Tamperer
Finland FL 77720

Finland

Int2med ltd UK Responsible PersonSuite 1 Unit A1 Tectonic Place Holyport Road
Berks SL6 2YE
Maidenhead
sl6 2ye
UK Responsible Person
United Kingdom
03/11/202212588
  • Orthopaedic bone pin bioabsorbable :
Bioretec LtdYrittajankulma 5 33710 Tempere
Finland
Tamperer
FL-33710

Finland

Int2med ltd UK Responsible PersonSuite 1 Unit A1 Tectonic Place Holyport Road
Berks SL6 2YE
Maidenhead
sl6 2ye
UK Responsible Person
United Kingdom
03/12/202212622
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Bioabsorbable long bone nail :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic bone screw starter/notcher :
  • ,
  • Surgical instrument/implant rack :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Manual surgical rotary handpiece reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • General internal orthopaedic fixation system implantation kit :
  • ,
  • Orthopaedic bone screw bioabsorbable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
  • ,
  • Orthopaedic bone wire :
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom







05/01/20157201
  • Total bilirubin IVD control :
  • ,
  • Multiple coagulation factor IVD control :
  • ,
  • Calcium chloride coagulation reagent IVD :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Haematological cell analyser IVD automated :
  • ,
  • Treponema pallidum total antibody IVD control :
  • ,
  • 125-Dihydroxy vitamin D3 IVD control :
  • ,
  • Superoxide dismutase (SOD) IVD control :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD calibrator :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD control :
  • ,
  • Lipoprotein A IVD calibrator :
  • ,
  • Non-esterified fatty acid IVD control :
  • ,
  • Total bilirubin IVD calibrator :
  • ,
  • C-reactive protein (CRP) IVD calibrator :
  • ,
  • C-reactive protein (CRP) IVD control :
  • ,
  • Citrate IVD calibrator :
  • ,
  • Citrate IVD control :
  • ,
  • Ferritin IVD calibrator :
  • ,
  • Ferritin IVD control :
  • ,
  • Retinol binding protein IVD control :
  • ,
  • Rheumatoid factor IVD calibrator :
  • ,
  • 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD reagent :
  • ,
  • Superoxide dismutase (SOD) IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
  • ,
  • Total cholesterol lipid IVD control :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Aldolase IVD calibrator :
  • ,
  • Aldolase IVD control :
  • ,
  • Angiotensin converting enzyme (ACE) IVD calibrator :
  • ,
  • Angiotensin converting enzyme (ACE) IVD control :
  • ,
  • Anti-A1 red blood cell grouping IVD lectin :
  • ,
  • Zinc IVD calibrator :
  • ,
  • Troponin I IVD kit rapid ICT clinical :
  • ,
  • Multiple drugs of abuse IVD kit rapid ICT clinical :
  • ,
  • Multiple cardiac marker IVD control :
  • ,
  • D-dimer IVD kit agglutination :
  • ,
  • D-dimer IVD control :
  • ,
  • D-dimer IVD calibrator :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD calibrator :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD control :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Cystatin C IVD calibrator :
  • ,
  • Cystatin C IVD control :
  • ,
  • Cystatin C IVD kit nephelometry/turbidimetry :
  • ,
  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis E virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis G virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple febrile infection-associated bacteria antigen IVD kit agglutination :
  • ,
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Rickettsia species (spotted fever group) total antibody IVD kit agglutination :
  • ,
  • Salmonella paratyphi total antibody IVD kit agglutination :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibrator :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagent :
  • ,
  • Treponema pallidum total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum total antibody IVD kit agglutination :
  • ,
  • Treponema pallidum total antibody IVD kit rapid ICT clinical :
  • ,
  • Treponema pallidum reagin antibody IVD kit agglutination :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
  • ,
  • Plasmodium falciparum antigen IVD kit rapid ICT clinical :
  • ,
  • Anti-H red blood cell grouping IVD lectin :
  • ,
  • Anti-Le^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Le^b red blood cell grouping IVD antibody :
  • ,
  • Anti-Lu^a red blood cell grouping IVD antibody :
  • ,
  • Anti-Lu^b red blood cell grouping IVD antibody :
  • ,
  • Anti-M red blood cell grouping IVD antibody :
  • ,
  • Anti-N red blood cell grouping IVD antibody :
  • ,
  • Anti-P1 red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS003] red blood cell grouping IVD antibody :
  • ,
  • Anti-S [MNS004] red blood cell grouping IVD antibody :
  • ,
  • ABO multiple blood grouping IVD kit agglutination :
  • ,
  • Bovine serum albumin (BSA) immunohaematology reagent IVD :
  • ,
  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD :
  • ,
  • Polyspecific antihuman globulin/complement IVD antibody :
  • ,
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD calibrator :
  • ,
  • Multiple electrolyte IVD calibrator :
  • ,
  • Multiple electrolyte IVD control :
  • ,
  • Calcium (Ca2+) IVD reagent :
  • ,
  • Chloride (Cl-) IVD reagent :
  • ,
  • Magnesium (Mg2+) IVD reagent :
  • ,
  • Inorganic phosphate (PO43-) IVD reagent :
  • ,
  • Potassium (K+) IVD reagent :
  • ,
  • Sodium (Na+) IVD reagent :
  • ,
  • Acid phosphatase isoenzyme IVD reagent :
  • ,
  • Alanine aminotransferase (ALT) IVD reagent :
  • ,
  • Aldolase IVD reagent :
  • ,
  • Alkaline phosphatase (ALP) isoenzyme IVD reagent :
  • ,
  • Total amylase IVD reagent :
  • ,
  • Angiotensin converting enzyme (ACE) IVD kit enzyme spectrophotometry :
  • ,
  • Aspartate aminotransferase (AST) isoenzyme IVD reagent :
  • ,
  • Pseudocholinesterase IVD reagent :
  • ,
  • Total creatine kinase (CK) IVD reagent :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD reagent :
  • ,
  • Beta-hydroxybutyrate dehydrogenase IVD reagent :
  • ,
  • Total lactate dehydrogenase (LDH) IVD reagent :
  • ,
  • Lipase IVD calibrator :
  • ,
  • Lipase IVD reagent :
  • ,
  • Ammonia IVD kit enzyme spectrophotometry :
  • ,
  • Ammonia IVD calibrator :
  • ,
  • Ammonia IVD control :
  • ,
  • Total bilirubin IVD reagent :
  • ,
  • Creatinine IVD reagent :
  • ,
  • Fructosamine IVD calibrator :
  • ,
  • Fructosamine IVD control :
  • ,
  • Fructosamine IVD reagent :
  • ,
  • Glucose IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Glycated haemoglobin (HbA1c) IVD reagent :
  • ,
  • Multiple lipid analyte IVD calibrator :
  • ,
  • Total cholesterol lipid IVD reagent :
  • ,
  • Non-esterified fatty acid IVD reagent :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD reagent :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD reagent :
  • ,
  • Lipoprotein A IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein A-II (Apo A2) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein B (Apo B) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein C-II (Apo C2) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein C-III (Apo C3) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein E (Apo E) IVD kit nephelometry/turbidimetry :
  • ,
  • Triglyceride IVD reagent :
  • ,
  • Microalbumin IVD kit nephelometry/turbidimetry :
  • ,
  • Microalbumin IVD calibrator :
  • ,
  • Microalbumin IVD control :
  • ,
  • Oxalate IVD calibrator :
  • ,
  • Oxalate IVD control :
  • ,
  • Oxalate IVD reagent :
  • ,
  • Prostacyclin IVD kit radioimmunoassay :
  • ,
  • Uric acid IVD reagent :
  • ,
  • Urea IVD reagent :
  • ,
  • Multiple clinical chemistry protein IVD calibrator :
  • ,
  • Multiple clinical chemistry protein IVD reagent :
  • ,
  • Albumin IVD reagent :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetry :
  • ,
  • Alpha-1-acid glycoprotein (orosomucoid) IVD reagent :
  • ,
  • Ceruloplasmin IVD reagent :
  • ,
  • Complement components C3/C3c IVD kit nephelometry/turbidimetry :
  • ,
  • Complement components C4/C4c IVD kit nephelometry/turbidimetry :
  • ,
  • C-reactive protein (CRP) IVD kit nephelometry/turbidimetry :
  • ,
  • Ferritin IVD kit nephelometry/turbidimetry :
  • ,
  • Haptoglobin IVD reagent :
  • ,
  • Homocysteine IVD calibrator :
  • ,
  • Homocysteine IVD control :
  • ,
  • Homocysteine IVD reagent :
  • ,
  • Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin E (IgE total) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetry :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD kit nephelometry/turbidimetry :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD reagent :
  • ,
  • Total iron binding capacity IVD (TIBC) reagent :
  • ,
  • Alpha-1-microglobulin IVD kit nephelometry/turbidimetry :
  • ,
  • Alpha-2-macroglobulin IVD kit nephelometry/turbidimetry :
  • ,
  • Myoglobin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Myoglobin IVD reagent :
  • ,
  • Prealbumin (transthyretin) IVD kit nephelometry/turbidimetry :
  • ,
  • Total protein IVD reagent :
  • ,
  • Troponin T IVD control :
  • ,
  • Troponin I IVD kit enzyme immunoassay (EIA) :
  • ,
  • Troponin I IVD calibrator :
  • ,
  • Troponin I IVD control :
  • ,
  • Troponin I IVD reagent :
  • ,
  • Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit chemiluminescent immunoassay :
  • ,
  • Human growth hormone (HGH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Insulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD kit chemiluminescent immunoassay :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD kit fluorescence immunoassay :
  • ,
  • Progesterone IVD kit chemiluminescent immunoassay :
  • ,
  • Progesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Prolactin IVD kit chemiluminescent immunoassay :
  • ,
  • Prolactin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit chemiluminescent immunoassay :
  • ,
  • Neonatal thyroid stimulating hormone (neonatal TSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free thyroxine (FT4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free thyroxine (FT4) IVD kit chemiluminescent immunoassay :
  • ,
  • Free triiodothyronine (FT3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free triiodothyronine (FT3) IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD calibrator :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD control :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD reagent :
  • ,
  • Copper IVD reagent :
  • ,
  • Iron IVD reagent :
  • ,
  • Zinc IVD reagent :
  • ,
  • Rheumatoid factor IVD kit nephelometry/turbidimetry :
  • ,
  • Rheumatoid factor IVD kit agglutination :
  • ,
  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple thyroid antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple-therapy therapeutic drug monitoring IVD control :
  • ,
  • Gentamicin therapeutic drug monitoring IVD reagent :
  • ,
  • Digoxin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Digoxin therapeutic drug monitoring IVD reagent :
  • ,
  • Carbamazepine therapeutic drug monitoring IVD reagent :
  • ,
  • Lithium therapeutic drug monitoring IVD reagent :
  • ,
  • Phenobarbital therapeutic drug monitoring IVD reagent :
  • ,
  • Phenytoin therapeutic drug monitoring IVD reagent :
  • ,
  • Valproic acid therapeutic drug monitoring IVD reagent :
  • ,
  • Multiple drugs of abuse IVD control :
  • ,
  • Amphetamine/methamphetamine group IVD reagent :
  • ,
  • Barbiturate IVD reagent :
  • ,
  • Cannabinoid IVD reagent :
  • ,
  • Cocaine/cocaine metabolite IVD reagent :
  • ,
  • Ethanol (ETOH) IVD reagent :
  • ,
  • Methadone IVD reagent :
  • ,
  • Methanol IVD reagent :
  • ,
  • Opiate/opiate metabolite IVD reagent :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD reagent :
  • ,
  • Erythrocyte sedimentation rate (ESR) IVD control :
  • ,
  • Activated partial thromboplastin time (APTT) IVD reagent :
  • ,
  • Prothrombin time (PT) IVD kit clotting :
  • ,
  • Thrombin time (TT) IVD kit clotting :
  • ,
  • Fibrinogen assay (factor I) IVD kit clotting :
  • ,
  • Coagulation factor II (prothrombin) IVD reagent :
  • ,
  • Coagulation factor V IVD reagent :
  • ,
  • Coagulation factor VIII IVD reagent :
  • ,
  • Coagulation factor X IVD reagent :
  • ,
  • Coagulation factor XI IVD reagent :
  • ,
  • Coagulation factor XII IVD reagent :
  • ,
  • Lupus anticoagulant marker IVD reagent :
  • ,
  • Coagulation factor VII IVD reagent :
  • ,
  • Coagulation factor IX IVD reagent :
  • ,
  • Fibrinogen degradation product (FDP) IVD kit agglutination :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory semi-automated :
  • ,
  • Ion-selective analyser IVD automated :
  • ,
  • Coagulation analyser IVD laboratory automated :
  • ,
  • Coagulation analyser IVD laboratory semi-automated :
  • ,
  • Chemiluminescent immunoassay analyser IVD semi-automated :
  • ,
  • Enzyme immunoassay (EIA) analyser IVD automated :
  • ,
  • Citrate IVD kit enzyme spectrophotometry :
  • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
  • ,
  • Total bile acid IVD reagent :
  • ,
  • Unsaturated iron binding capacity (UIBC) IVD reagent :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Total thyroxine (TT4) IVD kit chemiluminescent immunoassay :
  • ,
  • Total thyroxine (TT4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total triiodothyronine (TT3) IVD kit chemiluminescent immunoassay :
  • ,
  • Total triiodothyronine (TT3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Minichromosome maintenance protein 5 (MCM5) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Transferrin IVD kit nephelometry/turbidimetry :
  • ,
  • Multiple apolipoprotein IVD calibrator :
  • ,
  • Red cell antibody diluent IVD reagent :
  • ,
  • Neonatal thyroxine (neonatal T4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ion selective electrode (ISE) reference solution IVD reagent :
  • ,
  • Calcium (Ca2+) electrode IVD :
  • ,
  • Chloride (Cl-) electrode IVD :
  • ,
  • Reference electrode IVD :
  • ,
  • Hydrogen (H+)/pH electrode IVD :
  • ,
  • Potassium (K+) electrode IVD :
  • ,
  • Sodium (Na+) electrode IVD :
  • ,
  • Inherited haemoglobinopathy IVD control :
  • ,
  • Antioxidant capacity IVD calibrator :
  • ,
  • Antioxidant capacity IVD control :
  • ,
  • Antioxidant capacity IVD reagent :
  • ,
  • Carbon dioxide (CO2) IVD kit spectrophotometry :
  • ,
  • Carbon dioxide (CO2) IVD calibrator :
  • ,
  • Carbon dioxide (CO2) IVD control :
  • ,
  • Vitamin B12 IVD kit chemiluminescent immunoassay :
  • ,
  • Total testosterone IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple cardiac marker IVD kit rapid ICT clinical :
  • ,
  • Benzodiazepine group therapeutic drug monitoring IVD reagent :
  • ,
  • Pregnancy-associated plasma protein A (PAPP-A) IVD kit chemiluminescent immunoassay :
  • ,
  • Antithrombin III (ATIII) IVD kit nephelometry/turbidimetry :
  • ,
  • Total cortisol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species total antibody IVD kit agglutination :
  • ,
  • C-reactive protein (CRP) IVD kit agglutination rapid :
  • ,
  • Dengue virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Brucella melitensis total antibody IVD kit agglutination :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit agglutination rapid :
  • ,
  • Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit agglutination rapid :
  • ,
  • Multiple Rickettsia species (spotted fever/typhus groups) total antibody IVD kit agglutination :
  • ,
  • Orientia tsutsugamushi total antibody IVD kit agglutination :
  • ,
  • Glutathione reductase IVD kit enzyme spectrophotometry :
  • ,
  • Glutathione reductase IVD control :
  • ,
  • Glutathione peroxidase IVD kit enzyme spectrophotometry :
  • ,
  • Glutathione peroxidase IVD control :
  • ,
  • Total immunoglobulin E (IgE total) IVD kit nephelometry/turbidimetry :
  • ,
  • 17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple febrile infection-associated bacteria antibody IVD control :
  • ,
  • Urine test strip colour chart IVD :
  • ,
  • D-dimer IVD kit nephelometry/turbidimetry :
  • ,
  • C-peptide IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Fibrinogen (Factor I) assay IVD kit nephelometry/turbidimetry :
  • ,
  • Multiple Plasmodium species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Non-immunoglobulin allergic mediator/allergy cell marker reagent IVD :
  • ,
  • SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adenosine deaminase (ADA) IVD control :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Salmonella species total antibody IVD kit agglutination :
  • ,
  • Salmonella typhi total antibody IVD kit agglutination :
  • ,
  • Lactate IVD reagent :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Glutamate IVD reagent :
  • ,
  • Brucella abortus total antibody IVD kit agglutination :
  • ,
  • Adenosine deaminase (ADA) IVD calibrator :
  • ,
  • Haemoglobin detection IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1C) analyser IVD :
  • ,
  • Adenosine deaminase (ADA) IVD reagent :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit rapid ICT clinical :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinical :
  • ,
  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
  • ,
  • C-reactive protein (CRP) IVD kit rapid ICT clinical :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit immunochromatographic test (ICT) rapid professional/self-test :
  • ,
  • Neisseria gonorrhoeae antigen IVD kit rapid ICT clinical :
  • ,
  • Hepatitis A virus antigen IVD kit rapid ICT clinical :
  • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
  • ,
  • Salmonella typhi antigen IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Copper IVD control :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Syphilis Antigen Detection :
  • ,
  • TDM/Drug Standards / Calibrators :
  • ,
  • TDM/Drug Controls :
BIOS Health Ltd.8 Bateman Mews

Cambridge
CB2 1NN

England United Kingdom







04/24/202213763
  • Clinical management support software :
Bios s.r.l.Street & N° Via Guido Rossa 10/12

Vimodrone (MI)
20055

Italy

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
09/24/202117615
  • Radio-frequency skin contouring system :
  • ,
  • Multi-modality skin surface treatment system :
  • ,
  • Radio-frequency skin contouring system :
  • ,
  • Multi-modality physical therapy system :
Biosafe S.A.Route du Petit Eysins 1

Eysins
1262

Switzerland

Asymptote Ltd. Part of CytivaUK Responsible PersonSovereign House

Cambridge
CB249BZ
UK Responsible Person
United Kingdom
07/26/202116230
  • Blood centrifugation system processing unit :
  • ,
  • Blood centrifugation system containment kit :
  • ,
  • Blood centrifugation system containment kit :
  • ,
  • Blood/tissue storage/culture container :
  • ,
  • Cooling laboratory mixer :
  • ,
  • Cooling laboratory mixer :
  • ,
  • Cooling laboratory mixer :
  • ,
  • Blood centrifugation system containment kit :
  • ,
  • Cooling laboratory mixer solution transfer tubing :
  • ,
  • Blood centrifugation system containment kit :
  • ,
  • Blood centrifugation system containment kit :
BioScience GmbHWalsmuhler Strasse 18

Dummer
19073

Germany

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/10/202114586
  • Periodontal tissue reconstructive material :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
Biosculptor CorporationTrading as: Maramed Orthopedic Systems 2480 West 82nd Street

Hialeah
Florida 33016

United States

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL
UK Responsible Person
United Kingdom
04/13/202219076
  • Cranial orthosis :
  • ,
  • Hand orthosis :
  • ,
  • Wrist/hand/finger extension orthosis :
  • ,
  • Wrist immobilizer single-use :
  • ,
  • Arm splint system thermoplastic :
  • ,
  • Leg splint system thermoplastic :
  • ,
  • Ankle/foot orthosis :
  • ,
  • Upper-limb traction wrap/trap single-use non-sterile :
  • ,
  • Stockinette :
BIOSENSE WEBSTER INC.31 TECHNOLOGY DRIVE SUITE 200

IRVINE
CALIFORNIA 92618

United States

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

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
09/22/202117688
  • Intracardiac ultrasound imaging catheter steerable single-use :
  • ,
  • Cardiac mapping/endocardial-injection catheter :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Percutaneous radio-frequency ablation system generator :
  • ,
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Cardiac radio-frequency ablation system generator :
  • ,
  • Surgical irrigation pump :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac radio-frequency ablation system catheter :
  • ,
  • Cardiac mapping catheter percutaneous single-use : Cardiac mapping catheter percutaneous single-use Conformity Assessment Certificate Expired
  • ,
  • Electrical-only medical device connection cable reusable : Electrical-only medical device connection cable reusable Conformity Assessment Certificate Expired
  • ,
  • Cardiac radio-frequency ablation system catheter : Cardiac radio-frequency ablation system catheter Conformity Assessment Certificate Expired
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac mapping catheter percutaneous single-use :
BIOSENSE WEBSTER INC33 TECHNOLOGY DRIVE

IRVINE
CALIFORNIA 92618

United States

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

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
01/27/202111814
  • Cardiac mapping system reference patch :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Percutaneous radio-frequency ablation system generator :
  • ,
  • Intracardiac ultrasound imaging catheter steerable single-use :
  • ,
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac mapping/endocardial-injection catheter :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Electrical-only medical device connection cable reusable : Electrical-only medical device connection cable reusable Conformity Assessment Certificate Expired
  • ,
  • Cardiac radio-frequency ablation system generator :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac mapping catheter percutaneous single-use : Cardiac mapping catheter percutaneous single-use Conformity Assessment Certificate Expired
  • ,
  • Electrical-only medical device connection cable reusable : Electrical-only medical device connection cable reusable Conformity Assessment Certificate Expired
  • ,
  • Cardiac radio-frequency ablation system catheter : Cardiac radio-frequency ablation system catheter Conformity Assessment Certificate Expired
Biosense Webster (israel) Ltd4 Hatnufa Street

Yokneam 2066717
2066717

Israel

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

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
01/08/202111397
  • Cardiac mapping system :
  • ,
  • Cardiac mapping system :
Biosensors Europe SARue de Lausanne 29

Morges
1110

Switzerland

BIOSENSORS INTERNATIONAL UK LTDUK Responsible Person12 NEW FETTER LANE

LONDON
EC4A1JP
UK Responsible Person
England United Kingdom
04/19/202213833
  • Drug-coated-metal coronary artery stent :
  • ,
  • Bare-metal coronary artery stent :
  • ,
  • Coronary angioplasty balloon catheter basic :
  • ,
  • Coronary angioplasty balloon catheter drug-coated :
  • ,
  • Peripheral angioplasty balloon catheter drug-coated :
  • ,
  • Drug-eluting coronary artery stent bioabsorbable-polymer-coated : Drug-eluting coronary artery stent bioabsorbable-polymer-coated Conformity Assessment Certificate Expired
Biosensors Interventional Technologies Pte. Ltd.36 Jalan Tukang

Singapore
619266

Singapore

BIOSENSORS INTERNATIONAL UK LTDUK Responsible Person12 NEW FETTER LANE

LONDON
EC4A1JP
UK Responsible Person
England United Kingdom
04/19/202213509
  • Coronary angioplasty balloon catheter basic :
Biosigma S.p.AVia Valletta 6

Cantarana di Cona
Venice 30010

Italy

Mornington 2000 LLP trading as Sterilab ServicesUK Responsible Person18 Mornington Terrace

Harrogate
North Yorkshire HG1 5DH
UK Responsible Person
England United Kingdom
12/29/202121524
  • Assay container IVD single-use :
  • ,
  • Laboratory analyser cuvette IVD single-use :
  • ,
  • Microscope counting chamber IVD :
  • ,
  • Urine sediment IVD reagent :
  • ,
  • Centrifuge tube IVD :
  • ,
  • General specimen microscopy slide IVD single-use :
  • ,
  • General specimen container IVD no additive/medium :
Biosil Limited127 Deerdykes Way Westfield Industrial Estate

Cumbernauld
Glasgow G68 9HN

United Kingdom







04/09/20225564
  • Adhesive Plasters/Dressings/Tapes/Barrier Films :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Accessories For Implantable Devices (Non-Invasive) :
  • ,
  • Body And Cranio-Maxillofacial Contouring Implants :
Biosphere Medical SAParc des Nations – Paris Nord 2
383 Rue De La Belle Etoile
Roissy-en-France
Val-D'oise 95700

France

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

Reading
Berkshire RG6 1AZ
UK Responsible Person
England United Kingdom
03/19/202112796
  • Vascular guide-catheter single-use :
  • ,
  • Peripheral vascular guidewire manual :
  • ,
  • Chemotherapeutic agent embolization particle :
  • ,
  • Non-neurovascular embolization plug animal-derived :
  • ,
  • Embolization particle non-bioabsorbable :
BIOSTER a.s.Tejny 621

Veverská Bítýška
66491

Czechia

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
04/27/202113932
  • Plant polysaccharide haemostatic agent bioabsorbable :
BioSure Global Limited12 Barbers Road

London
E15 2PH

England United Kingdom







02/23/202223226
  • Nasal mucosa infection control gel :
BIOSYNEX SA22 Boulevard Sebastien Brant
ILLKIRCH-GRAFFENSTADEN
Strasbourg
Bas-Rhin 67400

France

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
06/30/202115647
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Vaginal pH screening IVD kit colorimetric dipstick self-testing :
  • ,
  • Insulin-like growth factor binding protein 1 (IGFBP-1) IVD kit rapid ICT clinical :
BIOSYNEX SWISS SARue De Romont 29-31

Fribourg
La Sarine 1700

Switzerland

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
06/30/202115648
  • D-dimer IVD kit rapid ICT clinical :
BIOSYSTEMS S.A.Costa Brava 30

Barcelona
08030

Spain

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
11/30/202120219
  • Multiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassay :
  • ,
  • Adrenal antibody IVD kit fluorescent immunoassay :
  • ,
  • Endomysium antibody (EMA) IVD kit fluorescent immunoassay :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD kit fluorescent immunoassay :
  • ,
  • Native DNA antibody (anti-nDNA) IVD kit fluorescent immunoassay :
  • ,
  • Smooth muscle antibody IVD control :
  • ,
  • Liver-kidney microsome 1 antibody (anti-LKM1) IVD control :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD control :
  • ,
  • Citrate IVD kit enzyme spectrophotometry :
  • ,
  • Phosphate buffer/Sorenson buffer solution IVD :
  • ,
  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD :
  • ,
  • Microscopy mounting medium IVD :
  • ,
  • Endomysium antibody (EMA) IVD control :
  • ,
  • Mitochondrial antibody M2 (anti-Mi2) IVD control :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD control :
  • ,
  • Intrinsic factor/parietal cell antibody IVD control :
  • ,
  • Faecal occult blood IVD kit agglutination :
  • ,
  • Faecal occult blood IVD calibrator :
  • ,
  • Faecal occult blood IVD control :
  • ,
  • Calprotectin IVD reagent :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Calprotectin IVD control :
  • ,
  • Islet cell antibody IVD kit fluorescent immunoassay :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassay :
  • ,
  • Skin antibody IVD kit fluorescent immunoassay :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD reagent :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit fluorescent immunoassay :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD control :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD reagent :
  • ,
  • Islet cell antibody IVD control :
  • ,
  • Native DNA antibody (anti-nDNA) IVD control :
  • ,
  • Skin antibody IVD control :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Faecal specimen collection kit IVD clinical :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory automated :
  • ,
  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD :
BIOTEC ITALIA S.R.L.Viale della Repubblica

DUEVILLE (VI)
20 - 36031

Italy

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

London
England W1B 5TF
UK Responsible Person
England United Kingdom
regulatory@biotecitaliauk.co.uk
01/10/202221139
  • Dermatological solid-state laser system :
  • ,
  • Ultrasonic skin contouring system :
  • ,
  • Deep-tissue electromagnetic stimulation system professional :
  • ,
  • Electroporation therapy system :
  • ,
  • Microwave diathermy treatment system :
  • ,
  • Radio-frequency fat liquefaction system :
BIOTEC s.r.l.Via Industria 53

Povolaro di Dueville
Vicenza 36031

Italy

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
11/05/202119856
  • Bone trephine :
  • ,
  • Surgical countersink reusable :
  • ,
  • Synthetic bone graft :
  • ,
  • Bone tap reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental osteotome :
  • ,
  • Dental torque wrench :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implant/instrument depth limiter :
Biotech Europe Meditech Inc LimitedAF2 IDA Business and Technology Park

Roscommon
F42 P862

Ireland

BIOTECH UK HEALTHCARE LIMITEDUK Responsible Person25 Leeming Road

Borehamwood
Hertfordshire WD6 4EB
UK Responsible Person
England United Kingdom
04/30/202114254
  • Synovial fluid supplementation medium :
  • ,
  • Dermal tissue reconstructive material microbe-derived :
  • ,
  • Vitreous/aqueous humour replacement medium intraoperative :
  • ,
  • Vitreous humour replacement medium postoperative :
  • ,
  • Ophthalmic surgical dye :
  • ,
  • Posterior-chamber intraocular lens pseudophakic : Posterior-chamber intraocular lens pseudophakic Conformity Assessment Certificate Expired
  • ,
  • Manual intraocular lens injector single-use : Manual intraocular lens injector single-use Conformity Assessment Certificate Expired
  • ,
  • Posterior-chamber intraocular lens pseudophakic : Posterior-chamber intraocular lens pseudophakic Conformity Assessment Certificate Expired
  • ,
  • Posterior-chamber intraocular lens pseudophakic : Posterior-chamber intraocular lens pseudophakic Conformity Assessment Certificate Expired
Biotech GmbHHagenauer Str. 17-19

Wiesbaden
65203

Germany

Calmedical LtdUK Responsible PersonLangton Kennels DUNS
TD11 3QN
Langton Kennels
TD11 3QN
UK Responsible Person
Scotland United Kingdom
02/14/202213441
  • Funnel chest remodelling bar :
Biotechni SASZ.I. Athelia II 178 avenue du serpolet

La Ciotat
Cedex F 13704

France

United Orthopedic Corporation (UK) LimitedUK Responsible PersonBaileys Barn Pimlico Farm
Austrey Lane
No Mans Heath
Warwickshire B79 0PF
UK Responsible Person
England United Kingdom
04/27/202213890
  • Revision coated femoral stem prosthesis :
BioTeke Corporation (Wuxi) Co. Ltd4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi

Jiangsu Province
214174

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
04/21/202112460
  • Oral/upper respiratory tract specimen collection swab :
  • ,
  • General specimen collection kit IVD clinical :
  • ,
  • Nucleic acid sample preparation instrument IVD automated :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical :
  • ,
  • Oral/upper respiratory tract specimen collection swab :
BIOTEKNE SRLVia della Bastia 9 Casalecchio di Reno (BO)

Bologna
40033

Italy

GG & BB LimitedUK Responsible PersonViking Business Centre Turnpike Close
Norwich
Norwich
Norfolk NR6 5BD
UK Responsible Person
England United Kingdom
05/04/202224500
  • Hypodermic needle single-use :
Bioteque Corporation5F-6 No. 23 Sec.1 Chang-An E Rd

Taipei 104
104

Taiwan

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH
UK Responsible Person
England United Kingdom
06/17/202115218
  • Wearable percutaneous catheter/tube holder :
  • ,
  • Haemodialysis needle :
  • ,
  • Closed-wound/centesis drainage receptacle :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Double-lumen haemodialysis catheter nonimplantable :
  • ,
  • Multi-purpose percutaneous abdominothoracic drainage catheter :
  • ,
  • Polymeric ureteral stent :
  • ,
  • Airway suction catheter :
  • ,
  • Cardiac/peripheral vascular guidewire single-use :
BIOTRONICS 3D LIMITED5 Greenwich View Place

London
E14 9NN

England United Kingdom

info@biotronics3d.com






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

Bulach
8180

Switzerland

BIOTRONIK UK LIMITEDUK Responsible PersonBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA
UK Responsible Person
United Kingdom
03/25/202112897
  • Bare-metal coronary artery stent :
  • ,
  • Drug-eluting coronary artery stent fully-bioabsorbable :
  • ,
  • Cardiac/peripheral vascular guidewire single-use :
  • ,
  • Peripheral angioplasty balloon catheter basic :
  • ,
  • Coronary angioplasty balloon catheter basic :
  • ,
  • Peripheral artery stent bare-metal :
  • ,
  • Bare-metal renal artery stent :
  • ,
  • Iliac artery stent bare-metal :
  • ,
  • Drug-eluting coronary artery stent bioabsorbable-polymer-coated :
  • ,
  • Peripheral angioplasty balloon catheter basic :
BIOTRONIK SE & Co. KGWoermannkehre 1

Berlin
12161

Germany

BIOTRONIK UK LIMITEDUK Responsible PersonBIOTRONIK House Avonbury Business Park

Bicester
OX26 2UA
UK Responsible Person
United Kingdom
03/08/202112556
  • Cardiac resynchronization therapy implantable pacemaker :
  • ,
  • Dual-chamber implantable pacemaker rate-responsive :
  • ,
  • Single-chamber implantable pacemaker rate-responsive :
  • ,
  • Dual-chamber implantable defibrillator :
  • ,
  • Cardiac resynchronization therapy implantable defibrillator :
  • ,
  • Pacing/defibrillation lead repair kit :
  • ,
  • Pacing/defibrillation lead cap :
  • ,
  • Implantable pulse generator port plug :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Pacing/defibrillation lead suture sleeve :
  • ,
  • Vascular catheter stylet :
  • ,
  • Endocardial pacing lead :
  • ,
  • Implantable cardiac monitor programmer/transmitter/alarm :
  • ,
  • Implantable cardiac monitor :
  • ,
  • Cardiac pulse generator reader home-use :
  • ,
  • Surgical screwdriver single-use sterile :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Intravascular catheter slitter :
  • ,
  • Implantable pacemaker analyser intraoperative :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Vein pick :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Cardiac radio-frequency ablation system generator :
  • ,
  • Cardiac electrophysiology stimulation system :
  • ,
  • External pacemaker transcutaneous pacing :
  • ,
  • Cardiac pulse generator programmer :
  • ,
  • Single-chamber implantable defibrillator :
  • ,
  • Coronary venous pacing lead :
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • Endocardial defibrillation lead :
  • ,
  • Cardiac pulse generator programmer :
  • ,
  • Implantable cardiac device management application software :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Implantable cardiac device management application software :
  • ,
  • Electrocardiographic lead set reusable :
Biovault Technical Ltd24 Brest Road Derriford

Plymouth
Devon PL6 5XP

England United Kingdom
01752753720
admin@biovault.com






04/09/20225524
  • Umbilical cord blood collection set :
Biovendor - Laboratorni medicina a.s.Karasek 1767/1

Brno
62100

Czechia

Oxford Biosystems LtdUK Responsible Person184B Park Drive Milton Park
Abingdon
Abingdon
Oxfordshire OX14 4SE
UK Responsible Person
United Kingdom
07/11/202225243
  • Cartilage oligomeric matrix protein (COMP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Corticosteroid-binding globulin (CBG) IVD kit enzyme immunoassay (EIA) :
Bioventus LLC4721 Emperor Blvd Suite 100

Durham
North Carolina 27703

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/03/202114355
  • Synovial fluid supplementation medium :
  • ,
  • Bone growth ultrasonic stimulator :
  • ,
  • Bone growth ultrasonic stimulator :
  • ,
  • Noninvasive device battery charger :
  • ,
  • Personal device holder single-use :
  • ,
  • Radiographic image marker manual :
Biover AGMüliweg 2

Hergiswil
6052

Switzerland

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
12/21/202120778
  • Suturing needle holder reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Surgical bulldog clamp single-use :
BioWave Corporation8 Knight St Suite 201 Norwalk CT 06851

Norwalk
CT 06851

United States

P14 Medical LtdUK Responsible Person65 Bath Road

Stroud
Gloucestershire GL5 3LA
UK Responsible Person
England United Kingdom
10/21/202118164
  • Transcutaneous electrical stimulation electrode adhesive pad :
  • ,
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
  • ,
  • Analgesic PENS system probe single-use :
  • ,
  • Analgesic transcutaneous electrical nerve stimulation system :
  • ,
  • Transcutaneous electrical stimulation electrode reusable :
Bioxal SARoute des Varennes

Chalon sur Saône
71100

France

Schülke & Mayr UK LtdUK Responsible PersonCygnet House

Sheffield
S9 1AT
UK Responsible Person
England United Kingdom
11/24/202120198
  • Medical device disinfection agent :
  • ,
  • Medical device disinfection agent :
bio.logis digital health GmbhAltenhöferallee 3
Frankfurt am Main
Frankfurt am Main
Darmstadt 60438

Germany

Mantara Health LtdUK Responsible PersonBloxham Business Centre Barford Road
Bloxham
Banbury
Oxfordshire OX15 4FF
UK Responsible Person
England United Kingdom
03/21/202223689
  • Human genomic analysis interpretive software :
Bio/Data Corporation155 Gibraltar Road

Horsham
PA 19044

United States

Alpha Laboratories LtdUK Responsible PersonUnit 40 Parham Drive

Eastleigh
Hampshire SO50 4NU
UK Responsible Person
United Kingdom
12/29/202121534
  • Platelet aggregation study IVD reagent :
  • ,
  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD reagent :
  • ,
  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD control :
  • ,
  • Platelet aggregation study IVD kit nephelometry/turbidimetry :
  • ,
  • Lupus anticoagulant marker IVD kit clotting :
  • ,
  • Platelet aggregation analyser IVD semi-automated :
BIP Biomedizinische Instrumente und Produkte GmbHAm Brand 1

Türkenfeld
82299

Germany

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

Winnersh
RG41 5TS
UK Responsible Person
England United Kingdom
09/07/202117359
  • Imaging lesion localization marker implantable :
  • ,
  • Side-notch biopsy gun handpiece/needle :
Birkbeck College University of LondonMalet Street

London
WC1E 7HX

United Kingdom







02/23/20165903
  • Self-care monitoring/reporting software :
Birmingham Biotech LTDBirmingham Research Park 97 Vincent Drive

Birmingham
B15 2SQ

England United Kingdom







12/07/202011084
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
  • ,
  • Human chorionic gonadotropin alpha-subunit (alpha-HCG) IVD kit rapid ICT clinical :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Nasal mucosa infection control gel :
Birmingham Community Healthcare NHS Foundation TrustUnit 3 Priestley Wharf 20 Holt Street

Birmingham
West Midlands B7 4BN

United Kingdom







04/09/20226150
  • Self-care monitoring/reporting software :
  • ,
  • Bar dental precision attachment :
  • ,
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental implant suprastructure temporary custom-made :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant welding system :
  • ,
  • Dental implantation drilling template custom-made :
  • ,
  • Dental base plate :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental veneer professional :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Denture clasp polymer preformed :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Root canal post custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic anchor plate :
  • ,
  • Orthodontic anchoring screw :
  • ,
  • Orthodontic appliance positioning tray :
  • ,
  • Orthodontic archwire/bracket ligature :
  • ,
  • Orthodontic band material :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic spring :
  • ,
  • Denture reliner elastic long-term :
Birmingham Orthotic Services LTDUnit E10 Hastingwood Industrial Park
Wood Lane Erdington
Birmingham
B24 9QR

England United Kingdom







01/07/202221862
  • Orthotic insole custom-made :
  • ,
  • Orthotic shoe custom-made :
  • ,
  • Ankle/foot orthosis :
  • ,
  • Head/neck immobilizer reusable :
  • ,
  • Orthotic shoe adapted :
BIRR Bio Sciences BVBreedstraat 17 Bergseweg 4

3633 AX Vreeland
3633

Netherlands

Hunter Scientific LtdUK Responsible PersonUnit 1 Priors Hall Widdington

Saffron Walden
Essex CB11 3SB
UK Responsible Person
United Kingdom
04/06/202218631
  • Mechanical pipette :
  • ,
  • Assisted reproduction needle single-use :
  • ,
  • Assisted reproduction microtool :
  • ,
  • Assisted reproduction procedure dish :
  • ,
  • Assisted reproduction centrifuge tube :
  • ,
  • General laboratory container single-use sterile :
Birthsparks LtdUnit A1a Olympic Business park Drybridge Road
Dundonald
Kilmarnock
Ayrshire KA2 9BE

Scotland United Kingdom
01563 851404






02/05/202211979
  • Birthing cushion :
Bisco Inc.1100 W. Irving Park Road

Schaumburg
IL 60193

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/18/202118324
  • Dental unfilled resin sealant/coating :
  • ,
  • Dentine bonding agent/set :
  • ,
  • Dental material application tool single-use :
  • ,
  • Dental composite resin :
  • ,
  • Dental etching solution :
  • ,
  • Dental material mixing surface single-use :
  • ,
  • Dental material mixing nozzle non-sterile :
  • ,
  • Dental material injection cannula single-use :
  • ,
  • Dental cement trial :
  • ,
  • Dental coating bond-reduction :
  • ,
  • Dental prosthesis priming agent :
  • ,
  • Dental composite resin kit :
  • ,
  • Dental restoration fixation cleaning solution :
  • ,
  • Dental etching solution syringe :
Bistos Co. Ltd.7th Fl. A Bldg Woolim Lions Valley 5-cha 302
Galmachi-ro Jungwon-gu
Seongnam-si
Gyeonggi-do 13201

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
09/21/202117737
  • Overhead infant phototherapy unit :
  • ,
  • Breast pump electric :
  • ,
  • Foetal cardiac monitor :
  • ,
  • Foetal Doppler system :
  • ,
  • Pulse oximeter :
  • ,
  • Head-worn lamp :
  • ,
  • Breast pump support kit reusable :
Bite Easy Dental Laboratory60A Eldon Street North

Barnsley
Yorkshire S71 1LQ

England United Kingdom







02/02/202211896
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Root canal post custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Dental cusp permanent :
  • ,
  • Dental cusp temporary :
  • ,
  • Resin dental inlay :
  • ,
  • Denture reliner hard :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental bridge ceramic :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental prosthesis veneer resin :
Biterite Ltd1019c Portsdown Mews

London
NW11 7ES

United Kingdom







06/09/20095496
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Root canal post custom-made :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Partial denture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Resin dental inlay :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Gold dental inlay :
  • ,
  • Dental implant suprastructure kit :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental bridge ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge metal-ceramic :
bitop AGStockumer Straße 28,

Witten
58453

Germany

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/27/202118511
  • Skin moisture barrier dressing :
  • ,
  • Oropharyngeal mucosa protection material :
  • ,
  • Nasal mucosa dressing non-antimicrobial :
  • ,
  • Eye lubricant :
Bittium Biosignals LtdPioneerinkatu 6 Pioneerinkatu 20

Kuopio
70800

Finland

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/24/202117826
  • Telemetric electrocardiographic ambulatory recorder :
  • ,
  • Cardiac electrophysiology application software :
  • ,
  • Electrocardiographic electrode single-use :
Bizztrex InternationalRchna Center Razi ENT Commissioner Road Bizztrex International Barlas street Kashmir road

Sialkot
Punjab 51310

Pakistan

BIZZTREX LTDUK Responsible Person37 heyford avenue

Bristol
BS5 6UD
UK Responsible Person
England United Kingdom
04/27/202213797
  • Wire cutter :
  • ,
  • Vaginal speculum reusable :
  • ,
  • Towel clamp reusable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical probe/cannula bending tool :
  • ,
  • Surgical gouge :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Amputation knife :
  • ,
  • Bone collection scraper :
  • ,
  • Bone file/rasp reciprocating reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Bone cutting forceps :
  • ,
  • Bone holding forceps :
  • ,
  • Bone hook :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Cannulated surgical drill bit reusable :
  • ,
  • Cast cutting scissors :
  • ,
  • Cast cutting shears :
  • ,
  • Chisel/osteotome blade handle :
  • ,
  • Paraffin wax knife :
  • ,
  • Percussion hammer manual :
  • ,
  • Periodontal curette :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Rib spreader reusable :
  • ,
  • Rubber dam clamp :
  • ,
  • Rubber dam kit :
  • ,
  • Scalpel handle reusable :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Soft-tissue surgical hook reusable :
  • ,
  • Suction/irrigation tubing reusable :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Surgical mallet head :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Nasal speculum reusable :
  • ,
  • Obstetrical forceps reusable :
  • ,
  • Orthodontic pliers :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Mechanical stethoscope :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Manual surgical saw blade rigid :
  • ,
  • Manual bone mill :
  • ,
  • Laryngoscope blade reusable :
  • ,
  • Instrument tray reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Fixed-diameter cervical dilator reusable :
  • ,
  • ENT diagnostic set :
  • ,
  • Ear speculum reusable :
  • ,
  • Laryngoscope handle reusable :
  • ,
  • Dental amalgam carrier :
  • ,
  • Dental amalgam well :
  • ,
  • Dental articulator :
  • ,
  • Dental cheek retractor professional reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental osteotome set :
  • ,
  • Dental restoration carver amalgam reusable :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Dental torque wrench adaptor :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental mirror reusable :
  • ,
  • Dissection kit :
  • ,
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
  • ,
  • Vascular scissors :
  • ,
  • Dental explorer :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Periodontal probe reusable :
BK Medical UK LtdGround Floor Unit 2 Hampton Lovett Industrial Estate

Droitwich Spa
Worcestershire WR9 0NX

England United Kingdom







01/27/202222407
  • General-purpose ultrasound imaging system :
  • ,
  • Surgical ultrasound imaging transducer :
  • ,
  • Surgical ultrasound imaging transducer :
  • ,
  • Rectal/vaginal ultrasound imaging transducer :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Rectal/vaginal ultrasound imaging transducer :
  • ,
  • Surgical ultrasound imaging transducer :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Oesophageal ultrasound imaging transducer reusable :
  • ,
  • Needle guide single-use :
  • ,
  • Needle guide reusable :
  • ,
  • Rectal/vaginal ultrasound imaging transducer :
  • ,
  • Foot-switch electrical :
  • ,
  • Radiography digital imaging system remote control :
  • ,
  • Needle guide reusable :
  • ,
  • Body-orifice ultrasound imaging transducer cover image-enhancement :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Needle guide single-use :
Black and Black Surgical5175 South Royal Atlanta Drive

Tucker
Georgia 30084

United States

Eurosurgical LtdUK Responsible PersonMerrow Business Park
Guildford
Guildford
Surrey GU4 7WA
UK Responsible Person
England United Kingdom
11/12/202119107
  • Suction/irrigation tubing single-use :
Black Swan Dental Limitedunit 36b Albion Mills
Albion Road Greengates
Bradford
West Yorkshire BD109TQ

England United Kingdom







02/21/20209629
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic retainer :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Dental prosthesis/implant abutment screw analog single-use :
  • ,
  • Partial denture :
Black Tie Medical Inc. DBA Tulip Medical Products4360 Morena Blvd. Suite 100

San Diego
California 92117

United States

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/10/202120433
  • Liposuction system cannula single-use :
  • ,
  • Liposuction system cannula single-use :
Blackpool Teaching Hospital NHS Foundation TrustWhinney Heys Road

Blackpool
Lancashire FY3 8NR

United Kingdom







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

United Kingdom







04/13/20228971
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Custom-made mouthguard :
  • ,
  • Ceramic dental inlay :
Blatchford Products LimitedLister Road

Basingstoke
Hampshire RG22 4AH

United Kingdom







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

Bordon
Hampshire GU35 9LU

United Kingdom







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

United States

Fannin (UK) LtdUK Responsible PersonUnit 100 Westminster Industrial Estate
Repton Road Measham
Swadlincote
Derbyshire DE12 7DT
UK Responsible Person
United Kingdom
08/11/202116645
  • Nerve-function monitor :
  • ,
  • Patient monitoring system module nerve location :
Blink Medical LtdUnit 40 Radway Road Shirley

Solihull
B90 4NS

United Kingdom







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

London
SW14 8QR

United Kingdom







04/11/20227180
  • Prescription spectacle lens custom-made :
BLiNK Software Ltd20 Bincote road

Enfield
EN27RB

United Kingdom







05/06/20209943
  • Cardiovascular risk/probability assessment interpretive software :
  • ,
  • Cardiovascular risk/probability assessment interpretive software :
Bliss Health Products Co. Ltd.No. 61 & No. 96 Zhaoyi Road Dongsheng Town

Zhongshan City Guangdong
528414

China

UK APLAN CORPORATION LTDUK Responsible PersonWandle House Associates 47 Wandle House
Wandle Road
CROYDON Surrey
CR0 1DF
UK Responsible Person
England United Kingdom
ukrp8506@gmail.com
03/24/202223821
  • Basic walking frame non-foldable :
  • ,
  • Basic walking frame foldable :
Blizzard Protection Systems LtdUnit 2 Coed-Y-Parc Industrial Estate

Bethesda
Gwynedd LL57 4YY

Wales United Kingdom







03/26/202112975
  • Rescue blanket reusable :
  • ,
  • Rescue blanket single-use :
BLOC PPE LTD26B Station Road

Magherafelt
County Derry BT45 5DN

Northern Ireland United Kingdom







07/08/202210684
  • Surgical/medical face mask single-use :
Bloomage Biotechnology Corp. Ltd.No.678 Tianchen St High-Tech Development Zone

Jinan
250101

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
08/17/202116839
  • Dermal tissue reconstructive material microbe-derived :