Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
Scott Specialties Inc512 M Street

Belleville
Kansas 66935

United States

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
04/06/202224046
  • Arm immobilizer :
  • ,
  • Shoulder immobilizer/orthosis reusable :
  • ,
  • Wrist/hand/finger stable-position orthosis :
  • ,
  • Knee support orthosis :
  • ,
  • Hand orthosis :
  • ,
  • Wrist orthosis :
  • ,
  • Multiple-joint arm orthosis :
  • ,
  • Hand/finger splint reusable :
  • ,
  • Wrist binder reusable :
  • ,
  • Scrotal support :
  • ,
  • Abdominal hernia truss reusable :
  • ,
  • Splint padding/strapping material :
  • ,
  • Rib/sternum binder reusable :
  • ,
  • Multiple-joint lower limb orthosis :
  • ,
  • Lumbar spine orthosis :
  • ,
  • Abdominal binder reusable :
Scottish Centre for Excellence in Dentistry335 Govan Road Watermark Business

Glasgow
Lanarkshire G51 2SE

United Kingdom







04/09/20226160
  • Dental Appliances/Prostheses :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Dental cusp permanent :
  • ,
  • Dental cusp temporary :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental veneer professional :
  • ,
  • Root canal post custom-made :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Mouthguard reusable :
  • ,
  • Dental implantation drilling template custom-made :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant suprastructure temporary custom-made :
  • ,
  • Orthodontic archwire :
  • ,
  • Orthodontic archwire/bracket ligature :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic anchor plate :
  • ,
  • Orthodontic appliance/positioning tray kit :
  • ,
  • Orthodontic space maintainer :
Scottish Health Innovations LtdAgamemnon Street Agamemnon St

Clydebank
Dunbartonshire G81 4DY

United Kingdom







05/30/20176320
  • Clinical information system web-based application software :
  • ,
  • Clinical information system web-based application software :
Scottish Orthodontics Ltd36 London Street
edinburgh
edinburgh
Lothian EH3 6NA

United Kingdom







06/14/20198098
  • Orthodontic appliance system bonded :
Scotts Opticians Ltd16 High Street Kingston

Kington
Herefordshire HR5 3AX

United Kingdom







04/10/20226598
  • Prescribed Spectacles :
Scotts Opticians58 Abbeygate Street

Bury St. Edmunds
Suffolk IP33 1LB

England United Kingdom







04/06/20223307
  • Prescribed Spectacles :
ScreenPoint Medical300
Toernooiveld Nijmegen
Nijmegen
Provincie Gelderland 6525 EC

Netherlands

FREYR LIFE SCIENCES LTDUK Responsible Person9 Greyfriars Road

Reading
Berkshire RG1 1NU
UK Responsible Person
England United Kingdom
UKRP@FREYRSOLUTIONS.COM
03/19/202112754
  • X-ray image interpretive software :
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
05/11/202114605
  • Total cholesterol lipid IVD reagent :
  • ,
  • Glucose/ketone/lipid profile IVD reagent :
  • ,
  • Triglyceride IVD reagent :
  • ,
  • Glucose/ketone/lipid profile IVD control :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT self-testing :
  • ,
  • Glucose analyser IVD home-use :
  • ,
  • Glucose IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapid :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • Multiple tropical viral pathogen antigen/antibody IVD kit rapid ICT clinical :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Fluorescent immunoassay analyser IVD laboratory semi-automated :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
  • ,
  • Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD reagent :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Dengue virus NS1 antigen IVD reagent :
  • ,
  • Norovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Dengue virus NS1 antigen IVD control :
  • ,
  • Clostridium difficile antigen IVD kit fluorescent immunoassay rapid :
  • ,
  • Zika virus antigen IVD kit fluorescent immunoassay rapid :
  • ,
  • Luteinizing hormone (LH) IVD kit fluorescent immunoassay rapid :
  • ,
  • Multiple respiratory virus antigen IVD kit rapid ICT clinical :
  • ,
  • Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinical :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD kit fluorescent immunoassay :
  • ,
  • Influenza A/B virus antigen IVD kit fluorescent immunoassay :
  • ,
  • Legionella pneumophila antigen IVD kit fluorescent immunoassay :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit fluorescent immunoassay :
  • ,
  • Streptococcus pneumoniae antigen IVD kit fluorescent immunoassay :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD point-of-care :
  • ,
  • Multiple tropical viral pathogen immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus antigen/antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus antigen IVD kit rapid ICT clinical :
  • ,
  • Procalcitonin (PCT) IVD kit fluorescent immunoassay :
  • ,
  • Fluorescent immunoassay analyser IVD laboratory semi-automated :
  • ,
  • Dengue virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Zika virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dengue virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dengue virus antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD control :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
  • ,
  • D-dimer IVD control :
  • ,
  • Luteinizing hormone (LH) IVD control :
  • ,
  • Multiple tropical viral pathogen antigen/antibody IVD kit rapid ICT clinical :
  • ,
  • Ebola virus antigen IVD kit rapid ICT clinical :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD control :
  • ,
  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD control :
  • ,
  • Interferon gamma release IVD control :
  • ,
  • Free thyroxine (FT4) IVD control :
  • ,
  • Faecal occult blood IVD control :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD control :
  • ,
  • Total thyroxine (TT4) IVD control :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple mosquito-borne flavivirus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple respiratory virus antigen IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 antigen IVD control :
  • ,
  • Interferon gamma release IVD kit fluorescent immunoassay :
  • ,
  • Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Legionella pneumophila antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • Chikungunya virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • Adenovirus antigen IVD kit fluorescent immunoassay :
  • ,
  • Free thyroxine (FT4) IVD kit fluorescent immunoassay :
  • ,
  • Total thyroxine (TT4) IVD kit fluorescent immunoassay :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Multiple-type gastrointestinal pathogen antigen IVD kit fluorescent immunoassay :
  • ,
  • Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVD :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • SARS-CoV-2 neutralizing antibody IVD kit fluorescent immunoassay rapid :
  • ,
  • Helicobacter pylori antigen IVD kit fluorescent immunoassay rapid :
  • ,
  • Evacuated blood collection tube IVD anticoagulant :
  • ,
  • SARS-CoV-2 total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Plasmodium species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme spectrophotometry :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD control :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Wuchereria bancrofti antigen IVD kit rapid ICT clinical :
  • ,
  • Hepatitis A virus antigen IVD kit rapid ICT clinical :
  • ,
  • Norovirus antigen IVD kit rapid ICT clinical :
  • ,
  • Troponin I IVD kit rapid ICT clinical :
  • ,
  • Capillary blood collection tube IVD no additive :
  • ,
  • Treponema pallidum total antibody IVD kit rapid ICT clinical :
  • ,
  • Treponema pallidum total antibody IVD control :
  • ,
  • Helicobacter pylori antigen IVD control :
  • ,
  • Treponema pallidum total antibody IVD kit fluorescent immunoassay :
  • ,
  • Thyroid stimulating hormone (TSH) IVD control :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit fluorescent immunoassay :
  • ,
  • Multiple cardiac marker IVD kit fluorescent immunoassay :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit fluorescent immunoassay :
  • ,
  • D-dimer IVD kit fluorescent immunoassay :
  • ,
  • Zika virus immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay :
  • ,
  • SARS-CoV-2/influenza A/B antigen IVD control :
  • ,
  • Plasmodium falciparum antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple Plasmodium species antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple gastrointestinal virus antigen IVD kit rapid ICT clinical :
  • ,
  • Rotavirus antigen IVD kit rapid ICT clinical :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical :
  • ,
  • Streptococcus pneumoniae antigen IVD kit rapid ICT clinical :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit fluorescent immunoassay :
  • ,
  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD control :
  • ,
  • Legionella pneumophila antigen IVD control :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD control :
  • ,
  • Streptococcus pneumoniae antigen IVD control :
  • ,
  • Respiratory syncytial virus (RSV) antigen IVD control :
  • ,
  • Interferon IVD kit enzyme immunoassay (EIA) :
  • ,
  • Troponin I IVD kit fluorescent immunoassay :
  • ,
  • Troponin I IVD control :
  • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
  • ,
  • Procalcitonin (PCT) IVD control :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD kit fluorescent immunoassay rapid :
  • ,
  • Total triiodothyronine (TT3) IVD kit fluorescent immunoassay :
  • ,
  • Albumin IVD kit fluorescent immunoassay :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit fluorescent immunoassay :
  • ,
  • Multidrug-resistant nontuberculous Mycobacterium (NTM) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type tropical pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Follicle stimulating hormone (FSH) IVD control :
  • ,
  • Norovirus antigen IVD control :
  • ,
  • Multiple gastrointestinal virus antigen IVD control :
  • ,
  • Influenza A/B virus antigen IVD control :
  • ,
  • Adenovirus antigen IVD control :
  • ,
  • Mycoplasma pneumoniae antigen IVD control :
  • ,
  • Mycoplasma pneumoniae total antibody IVD kit fluorescent immunoassay :
  • ,
  • Mycoplasma pneumoniae total antibody IVD control :
  • ,
  • Total triiodothyronine (TT3) IVD control :
  • ,
  • Mycoplasma pneumoniae antigen IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 neutralizing antibody IVD control :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit rapid ICT clinical :
  • ,
  • Microalbumin IVD control :
SD INNOVATION S.A.SSite Eiffel - ZAC Ban La Dame 48 Square Eugène Herzog

Frouard
54390

France

Diagnostica Stago UKUK Responsible Person2 Theale Lakes Business Park Moulden Way
Sulhamstead
Theale
RG7 4GB
UK Responsible Person
England United Kingdom
12/31/202121025
  • Platelet aggregation analyser IVD :
  • ,
  • Assay stirring set IVD :
  • ,
  • Assay container IVD single-use :
  • ,
  • Magnetic stirrer IVD :
sdc dental laboratoryUnit 4 Spa Road Industrial Estate Spa Road

Bolton
Lancashire BL1 4SS

United Kingdom







02/23/20166632
  • Custom-made dental crown polymer :
  • ,
  • Dental bridge ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Gold dental inlay :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Root canal post custom-made :
  • ,
  • Dental veneer professional :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental prosthesis veneer resin :
SDI Limited3-15 Brunsdon Street

Bayswater
Victoria 3153

Australia

SDI Dental Innovations LimitedUK Responsible PersonHunters Lodge Midhurst Road

Lavant
PO18 0DA
UK Responsible Person
England United Kingdom
04/22/202216580
  • Dental material application tool single-use :
  • ,
  • Dental material cartridge-plunging applicator two-component manual :
  • ,
  • Dental material injection cannula single-use :
  • ,
  • Dental unfilled resin sealant/coating :
  • ,
  • Dentifrice :
  • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
  • ,
  • Dental amalgam mixer :
  • ,
  • Dental/surgical polymerization lamp :
SDI Limited3-15 Brunsdon Street

Bayswater
Victoria 3153

Australia

SDI Dental Innovations LimitedUK Responsible PersonHunters Lodge Midhurst Road

Lavant
PO18 0DA
UK Responsible Person
England United Kingdom
04/22/202216913
  • Dentine bonding agent/set :
  • ,
  • Dental amalgam alloy :
  • ,
  • Dental etching solution :
  • ,
  • Glass ionomer dental cement :
  • ,
  • Dental coating tooth-desensitizing professional :
  • ,
  • Dental composite resin :
  • ,
  • Dental acrylic resin :
  • ,
  • Dental etching solution syringe :
SDPDMSociete de Production de Dispositif Medical 42
Rue De Longvic CHENOVE
Dijon
Cote D'or 21300

France

Urgo LtdUK Responsible PersonSullington Road
Shepshed
Loughborough
Leicestershire LE12 9JG
UK Responsible Person
England United Kingdom
03/28/202112938
  • Corn/callus dressing single-use :
  • ,
  • Ear canal irrigation kit reusable :
Sea-Band Ltd8 Hawley Road

Hinckley
Leicestershire LE10 0PR

United Kingdom







08/08/20198950
  • Acupressure wristband :
Seating Matters Ltd131 Carnamuff Road Ballykelly

Limavady
County Londonderry BT49 9JG

Northern Ireland United Kingdom
02877766624
contact@seatingmatters.com






04/11/20227146
  • Assistive ergonomic chair manually-adjusted :
  • ,
  • Manual hospital bed :
  • ,
  • Pressure Relief Devices And Accessories :
  • ,
  • Stretchers/Chairs/Hospital Trolleys (Patient Transport) :
Seawon Meditech Co. Ltd.33 Bucheon-ro 298 beon-gil

Bucheon-si
Gyeonggi-do 14487

South Korea

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
11/05/202118713
  • Balloon kyphoplasty kit :
  • ,
  • Endoscopic electrosurgical electrode bipolar single-use :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Blood cell harvesting system :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Bone marrow biopsy needle single-use :
  • ,
  • Lumbar decompression procedure kit :
  • ,
  • Haematological concentrate system preparation kit bone marrow concentration :
  • ,
  • Radio-frequency ablation system :
  • ,
  • Haematological concentrate/haemostatic agent applicator :
  • ,
  • General-purpose surgical suction system electric :
  • ,
  • Bone trephine tubing set :
  • ,
  • Epidural anaesthesia set non-medicated :
  • ,
  • Intravascular occluding funnel catheter :
  • ,
  • Epiduroscopic catheter :
  • ,
  • Orthopaedic cement non-antimicrobial :
  • ,
  • Bone marrow collection/transfusion set :
  • ,
  • Bone marrow collection/transfusion set :
Sebbin Groupe S.A.S39 Parc d'Activites Des Quatre Vents CS80010 Boissy I'Aillerie

Cergy-PontoiseCedex
95651

France

SEBBIN UK LTDUK Responsible Person01. Meadlake Place Thorpe Lea Road

Egham
Surrey TW20 8HE
UK Responsible Person
England United Kingdom
custserv@sebbin.uk
05/06/202214147
  • Autologous adipose tissue collection/washing set :
  • ,
  • Custom-made silicone-block reconstructive implant :
  • ,
  • Calf implant :
  • ,
  • Chin prosthesis :
  • ,
  • Gluteal implant :
  • ,
  • Invasive breast implant sizer fixed single-use :
  • ,
  • Malar prosthesis :
  • ,
  • Nasal cavity stent implantable :
  • ,
  • Silicone gel-filled breast implant smooth-surface :
  • ,
  • Silicone gel-filled breast implant textured-surface :
  • ,
  • Skin-port tissue expander :
  • ,
  • Testicle prosthesis :
  • ,
  • Saline-filled breast implant unstructured smooth-surface :
  • ,
  • Tissue expander injection port :
Sebia (UK) LTDRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB

England United Kingdom







02/03/202111961
  • Electrophoresis analyser IVD :
  • ,
  • Specimen processing instrument IVD :
  • ,
  • Clinical laboratory information system application software :
  • ,
  • Protein electrophoresis IVD kit electrophoresis :
  • ,
  • Beta-2-transferrin IVD kit electrophoresis :
SebiaSebia. Parc Technologique Leonard de Vinci CO 8010 Lisses

Evry
91108

France

Sebia (UK) LTDUK Responsible PersonRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB
UK Responsible Person
England United Kingdom
11/08/202118935
  • Kappa/lambda light chain immunoglobulin IVD antibody :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD control :
  • ,
  • Electrophoresis analyser IVD semi-automated :
  • ,
  • Electrophoresis analyser IVD :
SebiaParc Technologique Leonard de Vinci CO 8010

Evry
Lisses 91108

France

Sebia (UK) LTDUK Responsible PersonRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB
UK Responsible Person
England United Kingdom
12/17/202120585
  • Densitometry analyser IVD :
  • ,
  • Specimen processing instrument IVD :
  • ,
  • Multiple haemoglobin subtype IVD kit electrophoresis :
  • ,
  • Protein electrophoresis IVD kit electrophoresis :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
SebiaParc Technologique Leonard de Vinci CO 8010 Lisses

Evry
91108

France

Sebia (UK) LTDUK Responsible PersonRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB
UK Responsible Person
England United Kingdom
12/17/202120686
  • Electrophoresis analyser IVD :
  • ,
  • Haemoglobin detection IVD control :
  • ,
  • Multiple haemoglobin subtype IVD kit electrophoresis :
  • ,
  • Microplate IVD :
SebiaParc Technologique Leonard de Vinci CO 8010 Lisses

Evry
91108

France

Sebia (UK) LTDUK Responsible PersonRiver Court Meadows Business Park Station Approach Blackwater
Camberley
Camberley
Surrey GU17 9AB
UK Responsible Person
England United Kingdom
12/17/202120773
  • Electrophoresis analyser IVD :
  • ,
  • Specimen processing instrument IVD :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit electrophoresis :
  • ,
  • Carbohydrate deficient transferrin IVD reagent :
  • ,
  • Multiple clinical chemistry protein IVD reagent :
  • ,
  • Assay container IVD single-use :
  • ,
  • Wash/cleaning solution IVD manual equipment :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Carbohydrate deficient transferrin IVD kit electrophoresis :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD kit electrophoresis :
  • ,
  • Coagulation factor VIII-associated antigen IVD kit electrophoresis :
  • ,
  • Citrate staining/testing reagent IVD :
  • ,
  • Capillary blood collection tube IVD no additive :
  • ,
  • Instrument/analyser test tube rack holder IVD :
  • ,
  • Protein electrophoresis IVD reagent :
  • ,
  • Buffered sample diluent IVD manual :
  • ,
  • Immunoglobulin A antibody (anti-IgA) IVD reagent :
  • ,
  • Total immunoglobulin G (IgG total) IVD antibody :
  • ,
  • Total immunoglobulin M (IgM total) IVD antibody :
  • ,
  • Total immunoglobulin D (IgD total) IVD antibody :
  • ,
  • Total immunoglobulin E (IgE total) IVD antibody :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD reagent :
  • ,
  • Coagulation factor VIII-associated antigen IVD antibody :
  • ,
  • Transferrin IVD antibody :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Carbohydrate deficient transferrin IVD calibrator :
  • ,
  • Protein electrophoresis IVD control :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD control :
  • ,
  • Haemoglobin detection IVD control :
  • ,
  • Total alkaline phosphatase (ALP) IVD control :
  • ,
  • Assay container IVD reusable :
  • ,
  • Microplate/cuvette holder IVD :
  • ,
  • Densitometry analyser IVD :
  • ,
  • Carbohydrate deficient transferrin IVD control :
  • ,
  • Total lactate dehydrogenase (LDH) IVD control :
seca Ltd40 Barn Street

Birmingham
B5 5QB

United Kingdom







02/13/20198490
  • Patient-height measure :
  • ,
  • Chair scale electronic :
  • ,
  • Infant scale electronic :
  • ,
  • Bioelectrical body composition analyser :
  • ,
  • Infant scale mechanical :
  • ,
  • Stand-on floor scale mechanical :
  • ,
  • Stand-on floor scale electronic :
  • ,
  • Electromechanical device/system transport trolley :
  • ,
  • Multiple physiological parameter spot-check system clinical :
Sechrist Industries Inc.4225 E. La Palma Ave.

Anaheim
California 92807

United States

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
09/17/202117625
  • Oxygen/air breathing gas mixer hospital :
SECURMED S.p.AVia Monte Grappa 2/G

Thiene (VI)
36016

Italy

Compliance Solutions (Lifesciences) LtdUK Responsible PersonSuite 10 Dunswood House 1 Dunswood Road
Cumbernauld
Glasgow
G67 3EN
UK Responsible Person
United Kingdom
05/04/202224475
  • Non-wearable adult urine collection bag closed-ended :
  • ,
  • Non-wearable adult urine collection bag closed-ended :
Sedana Medical Ltd.Unit 2A The Village Centre Two Mile House

Naas
Kildare W91 PWH5

Ireland

QCS International LTD.UK Responsible PersonSuite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ
UK Responsible Person
Scotland United Kingdom
09/06/202117283
  • Isoflurane/sevoflurane recycling anaesthesia vaporizer :
  • ,
  • Anaesthesia Luer syringe non-sterile :
  • ,
  • Vial/bottle adaptor non-hermetic :
  • ,
  • Vial/bottle adaptor non-hermetic :
  • ,
  • Anaesthesia workstation gas scavenger :
  • ,
  • Anaesthetic gas scavenging unit :
  • ,
  • Isoflurane/sevoflurane recycling anaesthesia vaporizer :
SEDATELECChemin des Mûriers

Irigny
69540

France

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202216717
  • Ear microsystem needle :
  • ,
  • Ear microsystem needle :
  • ,
  • Fixed examination/treatment room light :
  • ,
  • Acupuncture electrical stimulation system :
  • ,
  • Musculoskeletal/physical therapy laser home-use :
See World Optical Co. LtdOptical Industrial Park SITU Town Danyang City

Jiangsu Province
212331

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
07/22/202225376
  • Pre-prescription spectacle lens :
SEED Co. Ltd1030-7 Fukuro

Kounosu
Saitama 369-0131

Japan

UltraVision International LimitedUK Responsible PersonCommerce Way

Leighton Buzzard
LU7 4RW
UK Responsible Person
United Kingdom
08/03/202217117
  • Soft corrective contact lens daily-wear :
  • ,
  • Soft corrective contact lens daily-disposable :
SEEDS Company LtdNo 705-16 Meshiro
Isahaya
Nagasaki
854-0007

Japan

Schuchmann LLPUK Responsible Person3 lakeside Court Flaxley Raod
Kingston Park Spalding
Peterborough
Cambridgeshire PE2 9FT
UK Responsible Person
United Kingdom
04/19/202221461
  • Assistive pushchair :
Seegene Inc.Taewon Bldg. 91 Ogeum-ro Songpa-gu

Seoul
05548

South Korea

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

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
08/11/202116731
  • Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • MERS-CoV nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Candida species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Nucleic acid sample preparation instrument IVD :
  • ,
  • Multiple-type vaginitis-associated organism nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Mycoplasma genitalium nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • MDR-TB/XDR-TB nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Mycobacterium tuberculosis complex species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type meningitis pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple antimicrobial resistance nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Helicobacter pylori nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Inherited thrombophilia IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
Seer medical Pty Ltd278 Queensberry Street

Melbourne
3000

Australia

Seer Medical UK Pty LtdUK Responsible PersonStudio G10.1 Battersea Studio 1
80 Silverthorne Rd
London
SW8 3HE
UK Responsible Person
England United Kingdom
09/15/202222337
  • Electroencephalographic ambulatory recorder :
  • ,
  • Electrocardiography telemetric monitoring system :
SEERS Medical LimitedKenton Road Debenham

Stowmarket
Suffolk IP14 6LA

England United Kingdom

cs@seersmedical.com






07/28/20107227
  • General-purpose stool/chair :
  • ,
  • Chair/stool armrest :
  • ,
  • Footrest :
  • ,
  • Anaesthetist's stool :
  • ,
  • Assistive ergonomic chair/table base :
  • ,
  • Coxit chair :
  • ,
  • Blood donor chair/couch :
  • ,
  • Ophthalmic chair manual :
  • ,
  • Massage table/couch line-powered :
  • ,
  • Massage table/couch non-powered non-portable :
  • ,
  • Examination/treatment table hydraulic :
  • ,
  • Magnetocardiography system gantry :
  • ,
  • Haemodialysis chair manual :
  • ,
  • Examination/treatment table line-powered :
  • ,
  • Blood donor chair/couch :
  • ,
  • Gynaecological operating table electromechanical :
  • ,
  • Gynaecological examination/treatment table manual :
  • ,
  • Haemodialysis chair electric :
  • ,
  • Ultrasound imaging system table non-powered :
  • ,
  • Ultrasound imaging system table powered :
  • ,
  • Hospital stretcher manual :
  • ,
  • Hospital stretcher manual :
  • ,
  • Hospital stretcher powered :
  • ,
  • Hospital stretcher powered :
  • ,
  • Hospital stretcher manual :
  • ,
  • Basic bed mattress :
  • ,
  • Intravenous pole :
  • ,
  • Examination/treatment table paper :
  • ,
  • Medical device service rail clamp :
  • ,
  • Massage table/couch non-powered non-portable :
  • ,
  • Massage table/couch line-powered :
  • ,
  • Physical therapy table line-powered :
  • ,
  • Bathing/changing table mobile :
  • ,
  • Massage table/couch non-powered portable :
  • ,
  • Examination/treatment table line-powered :
  • ,
  • Examination/treatment table hydraulic :
  • ,
  • Haemodialysis chair electric :
  • ,
  • Blood donor chair/couch :
  • ,
  • Ultrasound imaging system table powered :
  • ,
  • Gynaecological examination/treatment table manual :
  • ,
  • Gynaecological operating table electromechanical :
  • ,
  • Mobile bariatric examination/treatment chair electric :
SEFAM SAS144 Avenue Charles De Gaulle

NEUILLY-SUR-SEINE
92200

France

SEFAM Medical LtdUK Responsible PersonUnit 6 Blackthorn Way Five Mile Business Park Washingborough
Lincoln
Lincoln
Lincolnshire LN4 1BF
UK Responsible Person
England United Kingdom
10/20/202218979
  • CPAP/BPAP unit ambient air filter reusable :
  • ,
  • Heated respiratory humidifier :
  • ,
  • Home CPAP unit :
  • ,
  • Polygraph :
  • ,
  • Home BPAP unit :
Seffiline s.r.l.Seffiline s.r.l 98
Via delle Lame
Bologna
Emilia - Romagna 40122

Italy

Regenes UK LimitedUK Responsible Person52 Endeavour Rd

Cheshunt Waltham Cross
EN8 0LN
UK Responsible Person
England United Kingdom
04/24/202222559
  • Liposuction system :
  • ,
  • Liposuction system :
Segetex-eif26 bd Paul Vaillant-Couturier

Paris
Ivry-sur Seine 94200

France

Valmy SAS LtdUK Responsible Person24 Bedford Row

London
WC1R 4TQ
UK Responsible Person
England United Kingdom
10/11/202219153
  • Surgical/medical face mask single-use :
Sehar Batool InternationalS.I.E. Fateh Garh Near Umer Town

Sialkot
51310

Pakistan

HDJ Ltd UK Responsible Person13 Churchfields Avenue

Feltham
England Tw135pb
UK Responsible Person
England United Kingdom
06/10/202115173
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Scalpel reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Rectal dilator reusable :
  • ,
  • Towel clamp reusable :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Surgical gouge :
  • ,
  • Soft-tissue surgical hook reusable :
  • ,
  • Laryngeal knife :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Surgical mallet :
  • ,
  • Percussion hammer manual :
  • ,
  • Ear canal irrigation syringe :
  • ,
  • Eyelid speculum reusable :
  • ,
  • Dental spatula reusable :
  • ,
  • Nasal speculum reusable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental explorer :
  • ,
  • Manual dental scaler reusable :
  • ,
  • Rectal probe :
  • ,
  • Tonsil dissector reusable :
  • ,
  • Dental amalgam carrier :
  • ,
  • Cast cutting shears :
  • ,
  • Rib spreader reusable :
  • ,
  • Wire cutter :
  • ,
  • Wire holding/twisting pliers :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Instrument tray reusable :
  • ,
  • Laryngoscope handle reusable :
  • ,
  • Laryngoscope blade reusable :
  • ,
  • Dental mirror reusable :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Fistula probe :
  • ,
  • Manual surgical saw rigid :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Tongue depressor surgical :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Bone cutting forceps :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Tooth extraction forceps :
  • ,
  • Wire holding/twisting forceps :
  • ,
  • Obstetrical forceps reusable :
  • ,
  • Vaginal speculum single-use :
  • ,
  • Vaginal speculum reusable :
  • ,
  • Electrical-only medical device connection cable single-use :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrosurgical tip cleaning pad :
  • ,
  • ENT probe single-use :
  • ,
  • Ophthalmic soft-tissue manipulation forceps tweezers-like single-use :
  • ,
  • Ophthalmic soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • Surgical soft-tissue manipulation forceps alligator single-use :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like single-use :
  • ,
  • General-purpose surgical scissors single-use :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like single-use :
  • ,
  • Surgical irrigation/aspiration cannula non-illuminating single-use :
  • ,
  • Bone curette single-use :
  • ,
  • Suturing needle holder single-use :
  • ,
  • Scalpel single-use :
  • ,
  • Scalpel handle single-use :
  • ,
  • Manual scalpel blade single-use :
  • ,
  • Self-retaining surgical retractor single-use :
  • ,
  • Hand-held surgical retractor single-use :
  • ,
  • Fistula needle single-use :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar single-use :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Open-surgery electrosurgical handpiece/electrode monopolar reusable :
Seigla Medical Inc.7688 5th St SE

Buffalo MN
55313

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
02/01/202222486
  • Vascular guide-catheter extension :
Seiko Optical Products Co. Ltd18-10 Nihonbashi Hakozaki-cho Chuo-Ku

Tokyo
103-0015

Japan

Seiko Optical UKUK Responsible PersonNexus Court Gloucester Business Park
Brockworth
Gloucester
GL3 4AG
UK Responsible Person
England United Kingdom
07/13/202223271
  • Prescription spectacle lens non-customized :
Seiler Instrument & Manufacturing Co. Inc.3433 Tree Court Industrial Blvd.

St. Louis
Missouri MO 63122

United States

European Device Solutions LtdUK Responsible Person15 COANWOOD DRIVE Whitley Bay

WHITLEY BAY
TYNE AND WEAR NE25 9GB
UK Responsible Person
England United Kingdom
04/21/202224307
  • Colposcope :
  • ,
  • Dental surgical microscope :
  • ,
  • ENT surgical microscope :
Seirian Ltd30 Nant Y Felin Efail Isaf

Pontypridd
Mid Glamorgan CF38 1YY

United Kingdom







02/06/20133706
  • Dental Appliances/Prostheses :
Seirin Corporation1007-1 Sodeshi-cho Shimizu-Ku
Shizuoka City
Shizuoka
424-0037

Japan

Atlantic Bridge LimitedUK Responsible Person19 Willowside

Woodley
Berkshire RG5 4HJ
UK Responsible Person
United Kingdom
10/07/202116926
  • Acupuncture needle single-use :
  • ,
  • Moxa :
SEJONG MEDICAL Co. Ltd11 Sinchon 2-ro

Paju-si
Gyeonggi-do 10880

South Korea

Lawmed LtdUK Responsible Person1 Walton Lodge Bridge Street

Walton on Thames
Surrey KT12 1BT
UK Responsible Person
England United Kingdom
02/21/202223166
  • Laparoscopic multi-instrument access port single-use :
  • ,
  • Surgical wound protection ring :
  • ,
  • Laparoscopic access cannula single-use :
  • ,
  • Endoscopic electrosurgical electrode monopolar single-use :
  • ,
  • Tissue extraction bag :
Sekisui Diagnostics LLC6659 Top Gun Street

San Diego
CA 92121

United States

Sekisui Diagnostics (UK) LtdUK Responsible PersonSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ
UK Responsible Person
England United Kingdom
01/11/202221242
  • Multiple respiratory virus antigen IVD kit rapid ICT clinical :
  • ,
  • Epstein-Barr virus (EBV) heterophile antibody IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical :
  • ,
  • Trichomonas vaginalis antigen IVD control :
  • ,
  • Multiple respiratory virus antigen IVD control :
  • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Optical instrument performance standard calibrator/control IVD reusable :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza A/B virus antigen IVD control :
  • ,
  • SARS-CoV-2 antigen IVD control :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
SEKISUI DIAGNOSTICS P.E.I. Inc.70 Watts Avenue

Charlottetown
Prince Edward Island C1E 2B9

Canada

Sekisui Diagnostics (UK) LtdUK Responsible PersonSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ
UK Responsible Person
England United Kingdom
01/20/202221370
  • Unsaturated iron binding capacity (UIBC) IVD kit spectrophotometry :
  • ,
  • Albumin IVD kit spectrophotometry :
  • ,
  • Inorganic phosphate (PO43-) IVD kit spectrophotometry :
  • ,
  • Salicylate IVD calibrator :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD calibrator :
  • ,
  • Acetaminophen IVD calibrator :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometry :
  • ,
  • Uric acid IVD kit enzyme spectrophotometry :
  • ,
  • Salicylate IVD kit enzyme spectrophotometry :
  • ,
  • Carbon dioxide (CO2) IVD kit spectrophotometry :
  • ,
  • Acetaminophen IVD kit enzyme spectrophotometry :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometry :
  • ,
  • Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometry :
  • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
  • ,
  • Total creatine kinase (CK) IVD kit enzyme spectrophotometry :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometry :
  • ,
  • Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometry :
  • ,
  • Conjugated (direct) bilirubin IVD kit spectrophotometry :
  • ,
  • Creatinine IVD kit enzyme spectrophotometry :
  • ,
  • Glucose IVD kit enzyme spectrophotometry :
  • ,
  • Triglyceride IVD kit enzyme spectrophotometry :
  • ,
  • Microalbumin IVD kit nephelometry/turbidimetry :
  • ,
  • Microalbumin IVD calibrator :
  • ,
  • Urea IVD kit enzyme spectrophotometry :
  • ,
  • Total protein IVD kit enzyme spectrophotometry :
  • ,
  • Ethanol (ETOH) IVD kit enzyme spectrophotometry :
  • ,
  • Unsaturated iron binding capacity (UIBC) IVD calibrator :
SEKISUI MEDICAL CO. LTD.1-3 Nihonbashi 2-chome Chuo-ku

Tokyo
103-0027

Japan

Sekisui Diagnostics (UK) LtdUK Responsible PersonSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ
UK Responsible Person
England United Kingdom
12/22/202121453
  • Treponema pallidum reagin antibody IVD kit agglutination :
  • ,
  • Treponema pallidum reagin antibody IVD calibrator :
  • ,
  • Treponema pallidum reagin antibody IVD control :
  • ,
  • Treponema pallidum total antibody IVD kit agglutination :
  • ,
  • Treponema pallidum total antibody IVD calibrator :
  • ,
  • Treponema pallidum total antibody IVD control :
  • ,
  • Sialylated carbohydrate antigen KL-6 IVD kit enzyme immunoassay (EIA) :
  • ,
  • Sialylated carbohydrate antigen KL-6 IVD calibrator :
  • ,
  • Sialylated carbohydrate antigen KL-6 IVD control :
  • ,
  • Inherited haemoglobinopathy IVD kit liquid chromatography :
  • ,
  • High performance liquid chromatography analyser column IVD :
  • ,
  • Inherited haemoglobinopathy IVD calibrator :
  • ,
  • Inherited haemoglobinopathy IVD control :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit liquid chromatography :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • High performance liquid chromatography analyser IVD automated :
  • ,
  • Capillary blood collection tube IVD no additive :
  • ,
  • Assay container IVD single-use :
  • ,
  • Mechanical micropipette IVD :
  • ,
  • Pipette tip IVD :
Select Denture Centre95 Exeter Road

Exmouth
Devon EX8 1QD

United Kingdom







09/18/20013099
  • Dental Appliances/Prostheses :
Select Healthcare (UK) LtdUnit 2 Albert Road

Rushden
NN10 0BU

United Kingdom







03/09/20209678
  • Standing transfer platform manual :
  • ,
  • Patient lifting system divided leg sling :
  • ,
  • Mobile patient lifting system electrically-powered :
  • ,
  • Patient position turntable :
  • ,
  • Patient lifting system amputee sling :
  • ,
  • Patient transfer sliding mat :
  • ,
  • General-purpose patient lifting system sling/harness :
Select Medical Ltd.Unit 10 Phillips Road
Whitebirk Industrial Estate
Blackburn
BB1 5NA

England United Kingdom







02/24/202212295
  • Alternating-pressure chair cushion reusable :
  • ,
  • Alternating-pressure bed mattress :
  • ,
  • Foam bed mattress :
  • ,
  • Foam-filled chair cushion :
  • ,
  • Gel-filled chair cushion :
Select Research LtdMalvern Hill Science Park Geraldine Road

Malvern
Worcs WR14 3SZ

England United Kingdom







08/11/20176308
  • Standalone Software :
Select Specs LtdLockwoods Yard The Grove

Westgate-On-Sea
Kent CT8 8AS

England United Kingdom







02/24/20154450
  • Prescription spectacles :
SelfBack ltd27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom







01/24/202222315
  • Patient general health self-management software :
Selles Medical3-5 Popple Street

Hull
East Riding of Yorkshire HU9 1LP

United Kingdom







09/16/20199057
  • Infectious waste spill kit :
  • ,
  • Eye irrigation kit :
  • ,
  • Burn kit medicated :
  • ,
  • Burn kit non-medicated :
  • ,
  • First aid kit medicated :
  • ,
  • Anaphylactic kit :
  • ,
  • First aid kit non-medicated single-use :
SELVAS Healthcare Inc.155 Sinseong-ro Yuseong-gu

Daejeon
34109

South Korea

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
08/18/202116881
  • Bioelectrical body composition analyser :
  • ,
  • Noninvasive blood pressure physical simulator :
Semler Technologies Inc.4252 SE International Way Suite F

Wilwaukie
OR 97222

United States

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH
UK Responsible Person
England United Kingdom
10/01/202119016
  • Vascular compressor external :
  • ,
  • Radial artery compression device :
  • ,
  • Vascular compressor external :
Semperit Investments Asia Pte. Ltd.8 Jurong Town Hall Road #29-03 to 06
The JTC Summit
Singapore
609434

Singapore

Semperit Industrial Products Ltd.UK Responsible PersonCharter House 161
Newell Street
Birmingham
B3 1SW
UK Responsible Person
England United Kingdom
04/15/202211618
  • Hevea-latex surgical glove non-powdered non-antimicrobial :
  • ,
  • Polyisoprene surgical glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove powdered :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
Sendal S.L.Ctra. Nacional Madrid-Caceres s/n

Almaraz
Caceres 10350

Spain

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

Winnersh
RG41 5TS
UK Responsible Person
England United Kingdom
06/03/202115140
  • Secretion suction kit :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Suction/irrigation tubing single-use :
  • ,
  • Rectal irrigation kit :
  • ,
  • Suction/irrigation tubing single-use :
  • ,
  • Electronic gravity infusion controller administration set :
  • ,
  • Urological irrigation set :
  • ,
  • Electric infusion pump administration set single-use :
  • ,
  • Intravenous line stopcock :
  • ,
  • Catheter injection port :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Intravenous line filter :
Sengewald Klinikprodukte GmbhAlderstrasse 2 83101
Rohrdorf
Rohrdorf
83101

Germany

UK RepMed Ltd.UK Responsible PersonWey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT
UK Responsible Person
England United Kingdom
04/11/202224159
  • Patient surgical drape single-use :
  • ,
  • Skin-cover adhesive strip non-antimicrobial :
  • ,
  • Surgical gown single-use :
  • ,
  • Medical equipment drape single-use :
  • ,
  • Medical equipment drape single-use :
  • ,
  • Patient surgical drape single-use :
SenoRx Inc.1625 W 3rd Street

Tempe
Arizona 85281

United States

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

Winnersh
RG41 5TS
UK Responsible Person
England United Kingdom
03/19/202112795
  • Mammographic stereotactic biopsy system :
  • ,
  • Mammographic stereotactic biopsy system :
  • ,
  • Mammographic stereotactic biopsy system :
  • ,
  • Imaging lesion localization marker implantable :
  • ,
  • Soft-tissue biopsy procedure kit non-medicated :
  • ,
  • Mammographic stereotactic biopsy system :
  • ,
  • Soft-tissue biopsy procedure kit non-medicated :
SENSE4CARE S.L.Carrer Tirso de Molina 36 Office 18

Cornella de Llobregat
08940

Spain

Ever Pharma UK LtdUK Responsible PersonSuite 2 38 The Green South Bar Street

Banbury
Oxfordshire OX16 9AE
UK Responsible Person
England United Kingdom
06/13/202224929
  • Neuromuscular motion disorder ambulatory recorder/analyser :
Sensible Medical Innovations Ltd.Meir Ariel 6

Netanya
4250364

Israel

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
10/04/202118105
  • Whole-body plethysmograph :
Sensing Self Pte Ltd160 Robinson Road #20-03 Singapore Business Federation Ctr

Singapore
068914

Singapore

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
06/01/202115051
  • SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical :
Sensium Healthcare LTD115 Olympic Av Building 3
Milton Park
Abingdon
Oxon Ox14 4sa

England United Kingdom







09/13/202118573
  • Nurse call system :
Senslab GmbHBautzner Str. 67

Leipzig
04347

Germany

EKF Diagnostics Holdings plcUK Responsible PersonAvon House 19 Stanwell Road
Penarth
Cardiff
CF64 2EZ
UK Responsible Person
Wales United Kingdom
12/21/202120784
  • Lactate IVD kit rapid reduction/oxidation clinical :
SENSYNE HEALTH GROUP LIMITEDJohn Eccles House Robert Robinson Avenue

Oxford
Oxfordshire OX4 4GP

England United Kingdom

QARA@sensynehealth.com






11/29/20188208
  • Self-care monitoring/reporting software :
Sentec AGRingstrasse 39

Therwil
CH-4106

Switzerland

Sentec Medical Ltd.UK Responsible Person71-75 Shelton Street Covent Garden

London
WC2H 9JQ
UK Responsible Person
England United Kingdom
07/27/202216248
  • Transcutaneous blood gas monitor sensor :
  • ,
  • Transcutaneous blood gas monitoring system : Transcutaneous blood gas monitoring system Conformity Assessment Certificate Expired
Senti Tech Limited57 Jordan Street

Liverpool
Merseyside L1 0BW

England United Kingdom

phil.alton@senti.care






12/21/202011234
  • Wearable multiple physiological parameter recorder reusable :
Sentienx Sdn. Bhd.Lot 7 Jalan Hi-Tech 12 Zon Industri Fasa 3

Kulim Hi-Tech Park
Kedah 09090

Malaysia

TOP GLOVE MEDICAL UK LTDUK Responsible PersonVictoria House Suite 41
38 Surrey Quays Road
London
SE16 7DX
UK Responsible Person
England United Kingdom
09/02/202223820
  • Hevea-latex surgical glove powdered :
  • ,
  • Hevea-latex surgical glove non-powdered non-antimicrobial :
  • ,
  • Polyisoprene surgical glove non-powdered non-antimicrobial :
  • ,
  • Polychloroprene surgical glove non-powdered :
  • ,
  • Styrene-block-copolymer surgical glove non-powdered non-antimicrobial :
  • ,
  • Styrene-block-copolymer surgical glove non-powdered antimicrobial :
  • ,
  • Polychloroprene examination/treatment glove non-powdered :
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
08/10/202116678
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Unsaturated iron binding capacity (UIBC) IVD calibrator :
  • ,
  • Pseudocholinesterase IVD reagent :
  • ,
  • Alpha-hydroxybutyrate dehydrogenase IVD reagent :
  • ,
  • Lipase IVD calibrator :
  • ,
  • Lipase IVD control :
  • ,
  • Lipase IVD reagent :
  • ,
  • Ammonia IVD kit enzyme spectrophotometry :
  • ,
  • Creatinine IVD reagent :
  • ,
  • Fructosamine IVD calibrator :
  • ,
  • Ceruloplasmin IVD reagent :
  • ,
  • Kappa/lambda light chain immunoglobulin IVD reagent :
  • ,
  • Lithium therapeutic drug monitoring IVD reagent :
  • ,
  • Total bile acid IVD calibrator :
  • ,
  • Copper IVD kit spectrophotometry :
  • ,
  • Plasma protein IVD calibrator :
  • ,
  • C-reactive protein (CRP) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
  • ,
  • C-reactive protein (CRP) IVD calibrator :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
  • ,
  • Cystatin C IVD calibrator :
  • ,
  • Cystatin C IVD control :
  • ,
  • Cystatin C IVD reagent :
  • ,
  • Amylase isoenzyme IVD reagent :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD reagent :
  • ,
  • Ammonia IVD control :
  • ,
  • Iron IVD kit enzyme spectrophotometry :
  • ,
  • Fructosamine IVD kit enzyme spectrophotometry :
  • ,
  • Fructosamine IVD control :
  • ,
  • Cholinesterase dibucaine number (percentage inhibition) IVD reagent :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Plasma protein IVD control :
  • ,
  • Unsaturated iron binding capacity (UIBC) IVD kit spectrophotometry :
  • ,
  • Total bile acid IVD kit enzyme spectrophotometry :
  • ,
  • C-reactive protein (CRP) IVD reagent :
  • ,
  • Total bile acid IVD control :
  • ,
  • SARS-CoV-2 total antibody IVD control :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD kit nephelometry/turbidimetry :
  • ,
  • Albumin IVD reagent :
  • ,
  • Urea IVD reagent :
  • ,
  • Uric acid IVD reagent :
  • ,
  • Microalbumin IVD calibrator :
  • ,
  • Triglyceride IVD reagent :
  • ,
  • Apolipoprotein B (Apo B) IVD reagent :
  • ,
  • Apolipoprotein A-I (Apo A1) IVD reagent :
  • ,
  • Lipoprotein A IVD reagent :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD reagent :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD reagent :
  • ,
  • Total cholesterol lipid IVD reagent :
  • ,
  • Multiple lipid analyte IVD calibrator :
  • ,
  • Lactate IVD kit enzyme spectrophotometry :
  • ,
  • Glycated haemoglobin (HbA1c) IVD reagent :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Glucose IVD reagent :
  • ,
  • Alpha-1-acid glycoprotein (orosomucoid) IVD reagent :
  • ,
  • Haptoglobin IVD reagent :
  • ,
  • Homocysteine IVD kit enzyme spectrophotometry :
  • ,
  • SARS-CoV-2 total antibody IVD reagent :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD kit agglutination :
  • ,
  • Nucleic acid amplification mastermix kit IVD :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Zinc IVD kit spectrophotometry :
  • ,
  • Antithrombin III (ATIII) IVD reagent :
  • ,
  • Rheumatoid factor IVD reagent :
  • ,
  • Faecal occult blood IVD reagent :
  • ,
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Transferrin IVD reagent :
  • ,
  • Total protein IVD reagent :
  • ,
  • Plasma protein IVD reagent :
  • ,
  • Prealbumin (transthyretin) IVD reagent :
  • ,
  • Myoglobin IVD reagent :
  • ,
  • Beta-2-microglobulin IVD reagent :
  • ,
  • Alpha-2-macroglobulin IVD reagent :
  • ,
  • Homocysteine IVD control :
  • ,
  • Conjugated (direct) bilirubin IVD reagent :
  • ,
  • Total bilirubin IVD reagent :
  • ,
  • Lipase IVD kit enzyme spectrophotometry :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibrator :
  • ,
  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human herpesvirus 6 (HHV6) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD reagent :
  • ,
  • Herpes simplex virus 2 (HSV2) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Herpes simplex virus 1 (HSV1) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Angiotensin converting enzyme (ACE) IVD control :
  • ,
  • Angiotensin converting enzyme (ACE) IVD calibrator :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • Rheumatoid factor IVD calibrator :
  • ,
  • Myoglobin IVD calibrator :
  • ,
  • Lipoprotein A IVD control :
  • ,
  • Lipoprotein A IVD calibrator :
  • ,
  • Faecal occult blood IVD calibrator :
  • ,
  • Faecal occult blood IVD control :
  • ,
  • Beta-2-microglobulin IVD calibrator :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD reagent :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD calibrator :
  • ,
  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD control :
  • ,
  • Total lactate dehydrogenase (LDH) IVD reagent :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD reagent :
  • ,
  • Total creatine kinase (CK) IVD reagent :
  • ,
  • Aspartate aminotransferase (AST) isoenzyme IVD reagent :
  • ,
  • Angiotensin converting enzyme (ACE) IVD reagent :
  • ,
  • Total amylase IVD reagent :
  • ,
  • Alkaline phosphatase (ALP) isoenzyme IVD reagent :
  • ,
  • Aldolase IVD reagent :
  • ,
  • Alanine aminotransferase (ALT) IVD reagent :
  • ,
  • Total acid phosphatase (TAP) IVD reagent :
  • ,
  • Inorganic phosphate (PO43-) IVD reagent :
  • ,
  • Magnesium (Mg2+) IVD reagent :
  • ,
  • Calcium (Ca2+) IVD reagent :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Plasmodium malariae nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Plasmodium species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Leishmania species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple lipid analyte IVD control :
  • ,
  • Multiple respiratory virus nucleic acid IVD control :
  • ,
  • Clinical specimen extraction buffer IVD :
  • ,
  • Faecal occult blood immunoassay analyser IVD :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD reagent :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD calibrator :
  • ,
  • Calprotectin IVD reagent :
  • ,
  • Calprotectin IVD control :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Adenovirus nucleic acid IVD calibrator :
  • ,
  • Adenovirus nucleic acid IVD control :
  • ,
  • Adenovirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • BK virus (BKV) nucleic acid IVD control :
  • ,
  • BK virus (BKV) nucleic acid IVD calibrator :
  • ,
  • BK virus (BKV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Thermal cycler nucleic acid amplification instrument IVD manual :
  • ,
  • SARS-CoV-2 nucleic acid IVD control :
Sentiss Pharma Private LimitedVillage Khera Nihla Tehsil Nalagarh District Solan Himachal Pradesh

Tehsil Nalagarh
174101

India

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
11/04/202118765
  • Eye lubricant :
  • ,
  • Surgical/medical procedure irrigation fluid :
  • ,
  • Moisture/lubrication otic solution :
SentreHEART300 Saginaw Drive

Redwood City
California CA 94063

United States

AtriCure UK limitedUK Responsible Person1 Princeton Mews 167-169 London Road

Kingston Upon Thames
Surrey KT2 6PT
UK Responsible Person
England United Kingdom
02/17/202213108
  • Intravascular occluding balloon catheter image-guided :
  • ,
  • Open-surgery ligature loop :
  • ,
  • Cardiac/peripheral vascular guidewire single-use :
  • ,
  • Suture cutter single-use :
  • ,
  • Open-surgery ligator guide sheath :
  • ,
  • Suture/ligature tightener single-use :
Senzime ABUlls väg 41

Uppsala
756 51

Sweden

QAdvis UK LtdUK Responsible Person55-66 Frederick Street

Edinburgh EH2 1LS
EH2 1LS
UK Responsible Person
Scotland United Kingdom
01/19/202221241
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
  • ,
  • Block-monitoring peripheral nerve electrical stimulation system :
Seoil Pacific CorpSeoil Pacific Corporation Rm. 515-516 Ace Tower
5 Digitial-ro 26-gil
Seoul
Guro-gu 08389

South Korea

Remserve Medical Supplies LtdUK Responsible PersonEdwinstowe House High Street
Edwinstowe
MANSFIELD
Nottinghamshire NG21 9PR
UK Responsible Person
England United Kingdom
06/27/202217653
  • Chest-percussion airway secretion-clearing system :
  • ,
  • Ventilator breathing circuit single-use :
Septodont58 rue du Pont de Créteil

Saint-Maur-Des-Fossés
94107

France

Callisto Regulatory Consulting LimitedUK Responsible PersonThe Barn Holly Berry House Rough Park

Rugeley
Staffordshire WS15 3SQ
UK Responsible Person
England United Kingdom
12/29/202120947
  • Endodontic temporary cement :
  • ,
  • Clinical periodontal dressing :
  • ,
  • Root canal filling-removal solution :
  • ,
  • Dental anaesthesia injection kit :
  • ,
  • Dental syringe needle single-use :
  • ,
  • Silicone dental impression material :
  • ,
  • Alginate dental impression material :
  • ,
  • Gingival retraction kit :
  • ,
  • Gingival retraction solution :
  • ,
  • Dental mouthwash :
  • ,
  • Collagen haemostatic agent antimicrobial :
  • ,
  • Manual non-rotary dental instrument handle :
  • ,
  • Dentifrice :
  • ,
  • Hygroscopic dental cement :
  • ,
  • Zinc oxide eugenol dental cement :
  • ,
  • Dentine bonding agent/set :
  • ,
  • Manual non-rotary dental instrument handle :
SERB SAAvenue Louise 480

Brussels
1050

Belgium

Highbridge Pharma Services LtdUK Responsible PersonInternational House 24 Holborn Viaduct

London
EC1A 2BN
UK Responsible Person
England United Kingdom
05/27/202115002
  • Collagen haemostatic agent antimicrobial :
Serchem LtdHeatherset Arleston
Wellington
Telford
Shropshire TF1 2LY

United Kingdom







11/26/20199336
  • Medical device cleaning agent :
SERF85 Avenue des bruyères

Décines-Charpieu
69150

France

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
04/13/202214140
  • Instrument tray reusable :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Acetabular orthopaedic reamer :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Metallic acetabulum prosthesis :
  • ,
  • Orthopaedic implant/instrument assembling device :
  • ,
  • Orthopaedic implant/instrument assembling device :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Acetabulum prosthesis trial prefabricated reusable :
  • ,
  • Acetabular shell :
  • ,
  • Acetabular shell :
Seriderm UK Limited1 St James Court Whitefriars

Norwich
Norfolk NR3 1RU

England United Kingdom
0207 486 5429
info.uk@seriderm.com






04/15/202211313
  • Dermatological solid-state laser system :
  • ,
  • Dermatological frequency-doubled solid-state laser system :
  • ,
  • Dermatological carbon dioxide laser system :
  • ,
  • Multi-modality skin surface treatment system :
  • ,
  • Blue/red/infrared phototherapy lamp :
  • ,
  • Dermatological laser beam guiding handpiece :
  • ,
  • Electrosurgical system generator :
SERO ASStasjonsveien 44

Billingstad
1396

Norway

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
01/23/202222273
  • Multiple cardiac marker IVD control :
  • ,
  • Trisomy 21-risk hormone IVD control :
Serosep LimitedSerosep Limited Annacotty Business Park

Annacotty
V94 FF83

Ireland

Serosep UK LtdUK Responsible Person14 The Brunel Centre Newton Way

Crawley
RH10 9TU
UK Responsible Person
United Kingdom
02/28/202223301
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Clinical specimen extraction buffer IVD :
  • ,
  • Multiple antimicrobial resistance nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Neutral buffered formalin IVD :
  • ,
  • Pipetting system IVD :
  • ,
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple gastrointestinal virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple gastrointestinal disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT) :
Serres OyKeskustie 23

Kauhajoki
Länsi-Suomi 61850

Finland

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202215977
  • Suction system canister liner :
  • ,
  • Desk mount :
  • ,
  • Utility trolley :
  • ,
  • Stopcock :
  • ,
  • Surgical suction system collection container single-use :
  • ,
  • In-line backflow valve single-use :
  • ,
  • Suction/irrigation tubing single-use :
  • ,
  • General laboratory container single-use :
  • ,
  • Suction system canister liner :
  • ,
  • Surgical suction system collection container reusable :
  • ,
  • Infectious waste absorbent :
  • ,
  • Surgical fluid/smoke waste management system :
  • ,
  • Surgical suction system collection container single-use :
  • ,
  • Suction system canister liner :
Serrix B.V.Herengracht 458 CA

Amsterdam
1017

Netherlands

Profoot (UK) LtdUK Responsible PersonUnit G Penfold Works Imperial Way

Watford
Hertfordshire WD24 4YY
UK Responsible Person
United Kingdom
10/10/202220611
  • Nail infection solution :
Servicio Integral Hospitalario S.L.U.Autovía Madrid-Toledo Km. 63 300 Nº 9

Toledo
Olías del Rey 45280

Spain

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
11/21/202217427
  • Ophthalmic surgical procedure kit non-medicated single-use :
  • ,
  • Ophthalmic surgical procedure kit non-medicated single-use :
  • ,
  • Ophthalmic surgical procedure kit non-medicated single-use :
Servo-Dental GmbH & Co. KGRohrstraße 30

Hagen-Halden
58093

Germany

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
02/11/202221757
  • Resilient dental precision attachment :
servoprax GmbHAm Marienbusch 9

Wesel
46485

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202222473
  • Medical device cleaning/disinfection wipe :
  • ,
  • Dressing/utility forceps tweezers-like single-use :
  • ,
  • Intermittent electronic patient thermometer :
  • ,
  • Safety razor single-use :
  • ,
  • Rescue blanket reusable :
Set Medikal Sanayi ve Ticaret A.S.Osmangazi Mah. Maresal Fevz Cakmak Cad No:18

istanbul
Esenyurt 34522

Turkey

Vera Global LtdUK Responsible Person86-90 Paul Street 3rd Floor

London
EC2A 4NE
UK Responsible Person
England United Kingdom
07/27/202225432
  • Blood gas syringe IVD lithium heparin :
  • ,
  • Metered-delivery hypodermic syringe :
  • ,
  • Invasive blood pressure monitoring tubing set :
  • ,
  • Insulin syringe/needle basic :
  • ,
  • Vascular port administration set :
  • ,
  • General-purpose syringe single-use :
  • ,
  • Tuberculin/allergy syringe/needle basic :
  • ,
  • Hypodermic needle single-use :
SEWOON MEDICAL CO. LTD.60 Dorim-gil Ipjang-myeon Seobuk-gu

Cheonan-si
Chungcheongnam-do 31061

South Korea

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
09/13/202117388
  • Bare-metal duodenal stent :
  • ,
  • Polymer-metal duodenal stent :
  • ,
  • Bare-metal colonic stent :
  • ,
  • Polymer-metal colonic stent :
  • ,
  • Polymer-metal tracheal/bronchial stent :
  • ,
  • Polymer-metal oesophageal stent :
  • ,
  • Oesophageal stent reflux-control device sterile :
  • ,
  • Bare-metal biliary stent :
  • ,
  • Polymer-metal biliary stent non-bioabsorbable :
sfm medical devices GmbHBruckenstrasse 5

Waechtersbach
Hesse 63607

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202218690
  • Medication transfer needle filtering :
  • ,
  • Medication transfer set :
  • ,
  • Medication transfer set :
SG Diagnostics Pte LtdLevel 3 26 Ang Mo Kio Industrial Park 2

Singapore
569507

Singapore

Innova Medical (UK) Operations LtdUK Responsible PersonMarsland Chambers 1a Marsland Road
Sale
Cheshire
M33 3HP
UK Responsible Person
England United Kingdom
08/08/202225473
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
SGD Dental Ceramics85 Chester Road Castle

Northwich
Cheshire CW8 1HH

England United Kingdom







04/10/20226720
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Gold dental inlay :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Temporary dental crown/bridge :
SH Medical Salud Y Servicios Iberica S.LPaseo Del Delicias No 30 7th Floor

Madrid
Madrid 28045

Spain

Delta Surgical LimitedUK Responsible PersonUnit 10 Evolution Lymedale Business Park

Newcastle under Lyme
Staffordshire ST5 9QF
UK Responsible Person
United Kingdom
06/23/202225067
  • Medical equipment drape single-use :
Shaamil Floris74 Concorde Drive

Bristol
Avon BS10 6PX

United Kingdom







04/09/20225969
  • Dental Appliances/Prostheses :
Shamir Lens Thailand Co. Ltd101/106 Moo 20 Pahonyothin Road Khlong Nueng Khlong Luang

Pathumthani
12120

Thailand

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
07/08/202115837
  • Prescription spectacle lens non-customized :
Shamir Optical LdaRua do Cego 100

Vilar - Vila do Conde
4485-814

Portugal

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
06/08/202115085
  • Prescription spectacle lens non-customized :
Shamir Special Optical Products Ltd.Upper Galilee

Kibbutz Shamir
12135

Israel

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
10/26/202118571
  • Prescription spectacle lens non-customized :
Shamir UK LtdOmega House Anderson Road
Swavesey
Cambridge
Cambridgeshire CB24 4UQ

England United Kingdom







04/05/20222547
  • Spectacle Lenses :
  • ,
  • Spectacle Frames :
Shandon Diagnostics Limited a subsidiary of EprediaTudor Road Manor Park

Runcorn
Cheshire WA7 1TA

United Kingdom







04/07/20209799
  • Laboratory container/microscope slide robotic transfer system IVD :
  • ,
  • Sliding microtome IVD :
  • ,
  • Sliding microtome IVD :
  • ,
  • Tissue embedding unit IVD :
  • ,
  • Rotary microtome IVD :
  • ,
  • Paraffin-based embedding medium IVD :
  • ,
  • Cryostat microtome IVD :
  • ,
  • Tissue processor IVD automated/semi-automated :
  • ,
  • Cytological centrifuge IVD :
  • ,
  • Microscope slide digital imaging scanner IVD :
  • ,
  • Microscope slide coverslipper IVD :
  • ,
  • Microscope slide stainer IVD :
  • ,
  • Endocervical specimen cytological examination kit IVD :
Shandong Blue Sail Innovation Co. LtdEast Side of Xing'an Road Sixth Phase Project Zone Dongcheng Sub-district Offices

Linqu
Shandong 262600

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202212916
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove powdered :
Shandong Bohong Gene Technology Co. Ltd.1st Floor of Building 2 BIOBASE Headquarters North of Gangyuan 7th Road and West of Gangxingyuan Road Pilot Free Trade Zone of Jinan

Jinan
Shandong Province 250000

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
08/17/202225607
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Cytology specimen container IVD transport buffer :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
Shandong Chengwu Medical Products FactorySouthern End of Quancheng Road Chengwu County Heze City

Shandong Province
274200

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
11/14/202226910
  • Evacuated blood collection tube IVD no additive :
  • ,
  • Non-evacuated blood collection tube IVD no additive :
  • ,
  • Evacuated blood collection tube IVD clot activator :
  • ,
  • Non-evacuated blood collection tube IVD clot activator :
  • ,
  • Evacuated blood collection tube IVD clot activator/separator :
  • ,
  • Non-evacuated blood collection tube IVD clot activator/separator :
  • ,
  • Evacuated blood collection tube IVD anticoagulant :
  • ,
  • Evacuated blood collection tube IVD anticoagulant/antiglycolytic :
  • ,
  • Non-evacuated blood collection tube IVD anticoagulant :
  • ,
  • Non-evacuated blood collection tube IVD anticoagulant/antiglycolytic :
  • ,
  • Blood lancet single-use :
Shandong GD Technology Co. LtdNo. 19 East 1 Rd Liangxiang Industry Park Zibo

Shandong Province
255000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
11/23/202227070
  • Surgical/medical face mask non-antimicrobial single-use :
  • ,
  • Surgical gown single-use :
  • ,
  • Surgical cap single-use :
Shandong Harmowell Trade Co LtdD-1-619 Lvdi XinCheng
Huaiyin District
Jinan City
Shandong D-1-619

China

Albert Waeschle LtdUK Responsible Person11 Balena Close Creekmoor

Poole
Dorset BH17 7DB
UK Responsible Person
United Kingdom
03/24/202112827
  • Electronic thermometer probe cover :
Shandong Hengchang Medical Technology Co. Ltd.No.12 Sanying Road Science Tec. Park in Zhangdian

Zibo City
Shandong 255000

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
05/18/202114746
  • Vinyl examination/treatment glove non-powdered :
Shandong Huamei Technology Co. Ltd.588 Changning Street High-tech District Weifang

Shandong Province
261025

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
12/01/202227168
  • Dermatological diode laser system :
  • ,
  • Intense pulsed light skin surface treatment system :
  • ,
  • Skin photodynamic therapy/phototherapy lamp :
  • ,
  • Dermatological frequency-doubled solid-state laser system :
  • ,
  • Dermatological carbon dioxide laser system :
Shandong Huge Dental Material CorporationNo 68 Shanhai Road Donggang District

Rizhao City
Shandong Province 276800

China

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202211833
  • Orthodontic progressive aligner :
  • ,
  • Dental appliance fabrication material ceramic :
  • ,
  • Resin artificial teeth :
  • ,
  • Silicone dental impression material :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental casting wax :
  • ,
  • Dental impression tray single-use :
Shandong Intco Medical Products Co. Ltd.No.9888Qiwang Road Naoshan Industrial Park Qingzhou

Weifang Shandong
262500

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202216784
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Surgical/medical face mask antimicrobial single-use :
SHANDONG KANGLILAI MEDICAL APPARATUS CO. LTD.No. 8 Xinchang Road Weifang

Changyi
Shandong 261300

China

Conjoint Export Services (SA) Ltd.UK Responsible Person92 Brinkley Road

Worcester Park
Surrey KT4 8JF
UK Responsible Person
England United Kingdom
07/28/202116035
  • Basic intravenous administration set invasive :
  • ,
  • General-purpose syringe/needle :
  • ,
  • Hypodermic needle single-use :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Nasogastric feeding tube :
  • ,
  • Wearable adult urine collection bag open-ended :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Surgical/medical face mask single-use :
SHANDONG LEE MED TECHNOLOGY CO. LTD.NO.10 Sanying Road Technology Industrial Park

Zhangdian District
Zibo 255000

China

SPIRIT MEDICAL LTDUK Responsible PersonBROOK HOUSE 3A DUFFIELD ROAD
LITTLE EATON
NR DERBY
DERBYSHIRE DE215DR
UK Responsible Person
England United Kingdom
05/26/202114963
  • Surgical/medical face mask single-use :
Shandong Lianfa Medical Plastic Products Co. Ltd.No.1 Shuangshan Sanjian Road Zhangqiu City

Jinan
Shandong 250200

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
10/14/202118264
  • Blood lancet single-use :
  • ,
  • Manual blood lancing device reusable :
Shandong Shangwei Medical Products Co. Ltd.North of Fumin Avenue East Section Qinghe Sub-district Office Cao County

Heze
Shandong Province 274000

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
04/29/202224390
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove non-powdered :
Shandong Shingna Medical Products Co. Ltd.Shandong Shingna Medical Products Co. Ltd. No 3011 Qixiang Road
Zibo National New and Hi-tech Industrial Park Shangdon
Shandong
255086

China

Talley Group Ltd.UK Responsible PersonPremier Way Abbey Park Industrial Estate

Romsey
Hampshire SO519DQ
UK Responsible Person
United Kingdom
02/02/202222597
  • Synthetic polymer semi-permeable film dressing adhesive :
Shandong ThinkLab Biotechnology Co. Ltd.No.1 Building No.10 Industrial Park Jining Hi-tech Zone

Jining Shandong
272000

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/16/202211624
  • General specimen collection kit IVD clinical :
Shandong Weigao Blood Purification Products Co. Ltd.Shandong Weigao Blood Purification Products Co. Ltd. No.20 Xingshan Road
Weihai Torch Hi-Tech Science Park
Weihai
Shandong Province 264210

China

LUNDATEC UK LTDUK Responsible PersonFirst Floor 12 Commerce Road Lynch Wood

Peterborough
Cambridgeshire PE2 6LR
UK Responsible Person
England United Kingdom
08/05/202116553
  • Hollow-fibre haemodialysis dialyser single-use :
  • ,
  • Haemodialysis needle :
  • ,
  • Haemodialysis blood tubing set single-use :
SHANDONG XINGYU GLOVES CO. LTDMIDDLE YAOQIAN ROAD CHAOYANG DISTRICT

GAOMI
SHANDONG 261500

China

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

Walsall
West Midlands WS1 1NS
UK Responsible Person
England United Kingdom
11/05/202119823
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
Shandong Zhushi Pharmaceutical Group Co. LtdNo. 6 Shande Road Shan County

Heze City
Shandong 274300

China

HUMISS COMPANY LIMITEDUK Responsible PersonSuite 145 82-84 Bell Yard

London
WC2A 2JR
UK Responsible Person
England United Kingdom
09/29/202226206
  • Surgical/medical face mask non-antimicrobial single-use :
  • ,
  • Surgical gown single-use :
Shanghai 3F Electronics Co. Ltd.Building 3 128 Jiujing Rd. Songjiang High-tech Park

Shanghai
201615

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/10/202213256
  • Electromechanical device/system transport trolley :
Shanghai Anqing Medical Instrument Co. Ltd.3&4 Floor No. 2 Building 366 Huiqing Rd. East Zhangjiang High-Tech Park

Shanghai
201201

China

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/02/202117248
  • Endoscopic video image processing unit :
  • ,
  • Flexible video cystoscope single-use :
  • ,
  • Flexible video bronchoscope single-use :
  • ,
  • Flexible video choledochoscope single-use :
  • ,
  • Flexible video ureterorenoscope single-use :
Shanghai Apolo Medical Technology Co. Ltd.Room 301-310 Building 11 No. 388 Yindu Road Xuhui District

Shanghai
200231

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
07/13/202115912
  • General/multiple surgical diode laser system :
  • ,
  • General/multiple surgical carbon dioxide laser system :
  • ,
  • Dermatological diode laser system :
  • ,
  • Dermatological frequency-doubled solid-state laser system :
  • ,
  • Multi-modality skin surface treatment system :
  • ,
  • Skin photodynamic therapy/phototherapy lamp :
  • ,
  • Dermatological dye laser system :
  • ,
  • Intense pulsed light skin surface treatment system :
Shanghai Berry Electronic Tech Co. LtdUnit 104 1st Floor 7th Building No.1188 Lianhang Road Minhang District

Shanghai
201112

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
06/28/202225085
  • Pulse oximeter :
SHANGHAI BING FAN INDUSTRIAL CO. LTD.1st Building No. 18 Hangfan Road Pudong New Area

Shanghai
201316

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
09/07/202225485
  • Hot/cold therapy pack reusable :
Shanghai BioGerm Medical Technology Co. Ltd.Room 1302 1303 1304 1305 1306 1307 1309 Building 3 No. 1588 Huhang Road Fengxian District

Shanghai
201401

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
08/04/202225460
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
Shanghai Bionaire Biotech Co. Ltd.4F Building 1 No.105 Sinan Road Huangpu District

Shanghai
200025

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
11/05/202118726
  • SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical :
Shanghai Chenguang Medical Technologies Co. LtdNo.1269 Huaqing Road Qingpu

Shanghai
201707

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
12/08/202120392
  • MRI system coil radio-frequency :
Shanghai Chongjen Industry Co. Ltd.Room 402 Building 37 No. 258 Xinzhuang Road Caohejing Hi-tech Park Songjiang District

Shanghai
201612

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
07/04/202225170
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
Shanghai Chuangshi Industry (Group) Co. Ltd.No.388 Zhangliantang Road Qingpu District

Shanghai
201716

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
04/15/202217251
  • Exothermic heat therapy pack/patch :
  • ,
  • Hot/cold therapy pack single-use :
  • ,
  • Hot/cold therapy pack single-use :
Shanghai Conant Optics Co. Ltd.No. 555 Chuanda Road Pudong

Shanghai
201200

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
01/07/202221845
  • Prescription spectacle lens non-customized :
Shanghai Dochem Industries Co. LtdSuite E2014 2nd Floor No.3558 Zhenbei Road Putuo District

Shanghai
200062

China

HUA TENG LIMITEDUK Responsible Person3 Glass Street Hanley

Stoke On Trent
ST1 2ET
UK Responsible Person
England United Kingdom
09/13/202225975
  • Isolation gown single-use :
  • ,
  • Surgical gown single-use :
Shanghai Drager Medical Instrument Co Ltd3 No 229 Hupo Road Shanghai International Medical Zone
Pudong New Area
Shanghai
201321

China

Draeger Medical UK LtdUK Responsible Person The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW
UK Responsible Person
England United Kingdom
04/08/202213155
  • Bedside information system application software :
  • ,
  • General-purpose multi-parameter bedside monitor :
Shanghai Drager Medical Instrument Co. Ltd3 No 229 Hupo Road Shanghai International Medical Zone

Shanghai
201321

China

Draeger Medical UK LtdUK Responsible Person The Willows Mark Road Hertfordshire HP2 7BW

hemel hempstead
Hertfordshire HP2 7BW
UK Responsible Person
England United Kingdom
04/28/202212608
  • General-purpose multi-parameter bedside monitor :
Shanghai Everpure Medical Plastic Co. Ltd.No. 2418 Tingfeng Rd. Xinnong Town Jinshan District 201503

Shanghai
201503

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
01/04/202221031
  • Medical equipment handle cover single-use :
Shanghai Homelabs Medical Co. LtdRoom 301 No. 5 Lane 88 Shengrong Road China (Shanghai) Pilot Free Trade Zone.

Shanghai
201203

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
05/27/202224775
  • Faecal occult blood IVD kit rapid ICT clinical :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical :
  • ,
  • Multiple urine analyte IVD kit rapid colorimetric clinical :
  • ,
  • Multiple lipid analyte IVD kit rapid colorimetric clinical :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit fluorescent immunoassay rapid :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • Cystatin C IVD kit rapid fluorescent immunoassay clinical :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinical :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit rapid ICT clinical :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit rapid ICT clinical :
  • ,
  • Troponin I IVD kit fluorescent immunoassay :
  • ,
  • Helicobacter pylori antigen IVD kit rapid ICT clinical :
  • ,
  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD kit fluorescent immunoassay :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit rapid ICT clinical :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin-like growth factor binding protein 1 (IGFBP-1) IVD kit rapid ICT clinical :
  • ,
  • Rotavirus antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza A/B virus antigen IVD kit rapid ICT clinical :
  • ,
  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Microalbumin IVD kit rapid ICT clinical :
  • ,
  • Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD kit rapid ICT clinical :
  • ,
  • D-dimer IVD kit rapid ICT clinical :
  • ,
  • Luteinizing hormone (LH) IVD kit rapid ICT clinical :
  • ,
  • Multiple form 25-hydroxy vitamin D IVD kit fluorescent immunoassay rapid :
SHANGHAI HUVITZ Co. Ltd.Building 1 No. 150 Renjie Road Fengxian

Shanghai
201401

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202213380
  • Bench-top keratometer :
  • ,
  • Visual acuity projector :
  • ,
  • Hand-held subjective ophthalmic refractometer :
  • ,
  • Automated ophthalmic refractometer :
Shanghai ISO Medical Products Co. Ltd.999 Liu Chen Rd. Pudong New Area

Shanghai
201202

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202223228
  • Patient surgical drape single-use :
  • ,
  • Skin-closure adhesive strip :
  • ,
  • Radiopaque non-woven surgical sponge :
  • ,
  • General surgical procedure kit non-medicated single-use :
  • ,
  • Adhesive bandage :
  • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
  • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
  • ,
  • Absorbent underpad non-antimicrobial single-use :
  • ,
  • Synthetic polymer semi-permeable film dressing adhesive :
  • ,
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
  • ,
  • Wound-nonadherent dressing permeable non-antimicrobial :
  • ,
  • Synthetic polymer semi-permeable film dressing wound-nonadherent :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Eye pad :
  • ,
  • Woven gauze pad :
  • ,
  • Non-woven gauze pad :
  • ,
  • Cotton wool ball :
  • ,
  • Surgical scrub brush single-use :
  • ,
  • General-purpose bowl single-use :
  • ,
  • Dressing/utility forceps tweezers-like single-use :
  • ,
  • Pressure bandage non-latex single-use :
Shanghai Jianzhong Medical Packaging Co. LtdBldg 16 789# Puxing Road Minhang District

Shanghai
201114

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
11/05/202119729
  • Sterilization packaging single-use :
  • ,
  • Chemical/physical sterilization process indicator :
Shanghai Kindly Enterprise Development Group Co. Ltd.No. 658 Gaochao Road Jiading District

Shanghai
201803

China

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

Uxbridge
UB8 2DB
UK Responsible Person
England United Kingdom
10/01/202117945
  • Hypodermic needle single-use :
  • ,
  • General-purpose syringe/needle :
  • ,
  • Root canal irrigation blunt needle :
  • ,
  • Dental syringe needle single-use :
  • ,
  • Autoinjector needle :
  • ,
  • Non-fixed blood collection needle :
  • ,
  • Vascular catheter introduction needle :
  • ,
  • Cosmetic/aesthetic injection procedure kit :
  • ,
  • Metered-delivery hypodermic syringe/needle :
  • ,
  • Insulin syringe/needle basic :
  • ,
  • Basic intravenous administration set invasive :
  • ,
  • Electronic gravity infusion controller administration set :
  • ,
  • Intravenous administration tubing extension set :
  • ,
  • Stopcock :
  • ,
  • Intravenous line stopcock :
  • ,
  • ENFit oral/enteral syringe single-use :
  • ,
  • Umbilical cord clamp single-use :
  • ,
  • Basic intravenous administration set noninvasive :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Irrigation syringe :
  • ,
  • General-purpose syringe single-use :
  • ,
  • Anaesthesia Luer syringe :
  • ,
  • Medication transfer straw :
  • ,
  • Medication transfer needle filtering :
  • ,
  • Nasogastric feeding tube :
  • ,
  • Airway suction catheter :
  • ,
  • Single-administration urethral drainage catheter :
  • ,
  • Oxygen administration tubing :
  • ,
  • Manual enema device single-use :
  • ,
  • Luer-formatted protective cap :
  • ,
  • ENFit-formatted protective cap :
  • ,
  • NRFit-formatted protective cap :
  • ,
  • Luer-formatted bag access spike :
  • ,
  • Positive-pressure intravenous line needleless valve-connector :
  • ,
  • Negative-pressure intravenous line needleless valve-connector :
  • ,
  • Neutral-pressure intravenous line needleless valve-connector :
Shanghai Kindly Medical Instruments Co Ltd.No 925 Jinyuan yi Road

Shanghai
201803

China

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202221805
  • Pressure bandage non-latex single-use :
  • ,
  • Catheter/overtube balloon inflator single-use :
  • ,
  • Electronic gravity infusion controller administration set :
  • ,
  • Interventional radiology percutaneous-access kit single-use :
  • ,
  • Vascular catheter introduction needle :
  • ,
  • Vascular guidewire introduction sleeve :
  • ,
  • Vascular microcatheter :
  • ,
  • Intravenous administration tubing extension set :
  • ,
  • Angiographic catheter single-use :
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • Angiographic syringe :
  • ,
  • Stopcock :
  • ,
  • Coronary artery infusion catheter :
  • ,
  • Cardiac/peripheral vascular guidewire single-use :
Shanghai Kohden Medical Electronic Instrument Corp.Huancheng Bei Road 567

Shanghai
Fengxian District 201401

China

NIHONKOHDEN UK LTDUK Responsible PersonUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF
UK Responsible Person
England United Kingdom
admin@nihonkohden.co.uk
09/02/202217211
  • Electrocardiograph professional multichannel :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Centralized patient monitor :
  • ,
  • Intermittent electronic patient thermometer :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Rechargeable battery pack :
  • ,
  • Electrocardiographic lead set reusable :
Shanghai Link Instruments Co. Ltd.1101 Huyi Highway Nanxiang Town
Jiading Dstrict
Shanghai
201802

China

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

Berkhamsted
Hertfordshire HP41HL
UK Responsible Person
England United Kingdom
03/08/202223460
  • Automated lensmeter :
  • ,
  • Manually-adjusted lensmeter line-powered :
  • ,
  • Eye training model :
  • ,
  • Ophthalmic instrument table line-powered :
  • ,
  • Trial lens set :
  • ,
  • Visual acuity light box :
  • ,
  • Trial lens clip :
Shanghai MediWorks Precision Instruments Co. Ltd.No.7 MingPu Phase II No.3279 SanLu Road MinHang District

Shanghai
201100

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
10/21/202226613
  • Ophthalmic slit lamp examination :
  • ,
  • Ophthalmic slit lamp examination :
  • ,
  • Hand-held magnifier :
  • ,
  • Vision testing/training chart :
  • ,
  • Ophthalmic fundus camera :
  • ,
  • Ophthalmic surgical microscope :
  • ,
  • Dental surgical microscope :
  • ,
  • Ophthalmic tonometer manual :
  • ,
  • Hand-held subjective ophthalmic refractometer :
  • ,
  • Eye anterior segment analyser :
Shanghai MicroPort Endovascular MedTech (Group) Co. LtdBuilding 1 3399 Kangxin Road

Shanghai
201318

China

Lombard Medical LimitedUK Responsible Person4 Trident Park

Didcot
Oxfordshire OX11 7HJ
UK Responsible Person
England United Kingdom
04/09/202113246
  • Descending thoracic aorta endovascular stent-graft :
  • ,
  • Abdominal aorta endovascular stent-graft non-medicated :
  • ,
  • Peripheral angioplasty balloon catheter drug-coated :
  • ,
  • Peripheral angioplasty balloon catheter basic :
  • ,
  • Descending thoracic aorta endovascular stent-graft :
Shanghai Realbio Technology Co. Ltd.Room 302 Building 6 Xinjunhuan Road 138 Minhang District

Shanghai
201100

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
10/17/202226487
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
Shanghai Reyoungel Medical Technology Company LimitedFloor 15 Building 2# No.1809 Qixin Road Minhang District

Shanghai
201100

China

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

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
11/09/202118987
  • Dermal tissue reconstructive material microbe-derived :
Shanghai Sanyou Medical Co. Ltd.385 Huirong Road Jiading District

Shanghai
201815

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
12/01/202227153
  • Bone-screw internal spinal fixation system non-sterile :
  • ,
  • Polymeric spinal interbody fusion cage :
  • ,
  • Spinal fixation plate non-bioabsorbable :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
Shanghai Seegen Photoelectric Technology Co LtdFloor 3 Building 1 No.4299 Jindu Road
Minhang District
Shanghai
201108

China

Compliance Solutions (Lifesciences) LtdUK Responsible PersonSuite 10 Dunswood House 1 Dunswood Road
Cumbernauld
Glasgow
G67 3EN
UK Responsible Person
United Kingdom
06/28/202115496
  • Flexible video choledochoscope single-use :
  • ,
  • Flexible video ureteroscope single-use :
  • ,
  • Endoscopic video image processing unit :
Shanghai Shape Memory Alloy Co. Ltd.1F and 5F Tower 41 No. 258 Xinzhuan Road Songjiang High-Tech Park
CaoHeJing Development District
Shanghai
201612

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
10/21/202226627
  • Cardiac occluder delivery kit :
  • ,
  • Intravascular extraction catheter-snare :
  • ,
  • Cardiac defect occluder :
Shanghai Siyi Intelligent Technology Co. Ltd East Area 5F No.26 Lane 3399 Kangxin Road

Shanghai
Pudong New Area .

China

Rebotics Technology LimitedUK Responsible Person18 Lodge Road Hanborough Business Park
Long Hanborough Oxford
Long Hanborough
Oxfordshire OX29 8LJ
UK Responsible Person
England United Kingdom
03/10/202223564
  • Hand/wrist continuous passive motion exerciser :
SHANGHAI SPICA MANAGEMENT CONSULTING CO. LTD6/F No.133 Shengang Avenue Pudong District

Shanghai
201306

China

HUA TENG LIMITEDUK Responsible Person3 Glass Street Hanley

Stoke On Trent
ST1 2ET
UK Responsible Person
England United Kingdom
02/10/202222900
  • Medical bag :
SHANGHAI XIAOU INDUSTRY CO. LTDROOM 1502 BUILDING A
No.777 HUOSHAN ROAD
SHANGHAI
200882

China

Spec-Care LtdUK Responsible PersonUnit 8 Kingfisher Court Venny Bridge

Exeter
Devon EX4 8JN
UK Responsible Person
England United Kingdom
info@speccareservices.co.uk
05/27/202224792
  • Spectacle frame :
SHANGHAI ZJ BIO-TECH CO. LTD1st Floor Gate B Building #20 & 1st Floor Gate A Building #21 528 Ruiqing Road Zhangjiang High-Tech Industrial East District

Shanghai
201203

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
11/03/202226843
  • Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Magnetic particle separation instrument IVD :
Shangxian Minimal Invasive Inc.1st Floor Block B2-2 China medicine innovation park Mulan road Hi-tech development zone

Benxi
Liaoning 117004

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
01/06/202221807
  • Gastrointestinal endoscopic clip short-term :
  • ,
  • Endoscope observation cap single-use :
  • ,
  • Endoscope transport/sterilization protective cover single-use :
  • ,
  • Gastrointestinal endoscopic clip applier :
Shantou Institute of Ultrasonic Instruments Co. Ltd.#77 Jinsha Road

Shantou Guangdong
515041

China

Finger On Pulse Ltd.UK Responsible Person71 Durham Road

Bromley
Kent BR20SP
UK Responsible Person
England United Kingdom
10/11/202118143
  • Portable basic diagnostic x-ray system digital :
  • ,
  • Diagnostic x-ray system generator portable :
  • ,
  • General-purpose ultrasound imaging system :
Shanxi Regent Works IncNo.9 Xinhe Road Private Economic Zone Taiyuan

Shanxi Province
030043

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
03/16/202223594
  • Lumbar spine orthosis :
  • ,
  • Tubular support bandage non-latex reusable :
Shaoxing Fuqing Health Products Co. Ltd.No.599 Wuxie Road High-Tech Industrial Development Zone

Shaoxing
Zhejiang 312000

China

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

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202216911
  • Wound dressing kit medicated :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Face splash shield single-use :
  • ,
  • Isolation gown single-use :
  • ,
  • General surgical procedure kit non-medicated single-use :
SHAOXING YIBON MEDICAL CO. LTD.341 YUEWANG ROAD PAOJIANG INDUSTRIAL ZONE SHAOXING ZHEJIANG CHINA 347 YUEWANG ROAD PAOJIANG INDUSTRIAL ZONE SHAOXING ZHEJIANG CHINA

PAOJIANG INDUSTRIAL ZONE/ SHAOXING
ZHEJIANG Province 312000

China

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
08/24/202117027
  • Non-woven gauze pad non-sterile :
  • ,
  • Cotton wool ball :
  • ,
  • Pressure bandage non-latex single-use :
  • ,
  • Woven gauze pad non-sterile :
  • ,
  • Surgical scrub brush single-use :
  • ,
  • Antiseptic swab :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Medicine cup single-use :
  • ,
  • General-purpose bowl single-use :
  • ,
  • Surgical cap single-use :
  • ,
  • Tongue depressor surgical :
  • ,
  • Rescue blanket reusable :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Isolation gown single-use :
  • ,
  • Shoe cover :
  • ,
  • Cotton wool ball sterile :
  • ,
  • Non-woven gauze pad :
  • ,
  • Wound-nonadherent dressing absorbent non-antimicrobial :
  • ,
  • Woven gauze roll :
  • ,
  • Eye pad :
  • ,
  • Haemodialysis system dialyser holder :
  • ,
  • Adhesive bandage :
  • ,
  • Wound dressing kit non-medicated :
  • ,
  • Patient surgical drape single-use :
  • ,
  • Suture removal kit :
  • ,
  • Skin stapler/staple non-bioabsorbable :
  • ,
  • General-purpose bowl single-use :
  • ,
  • Exudate-absorbent dressing non-gel non-antimicrobial :
  • ,
  • Wound dressing kit medicated :
  • ,
  • Bandage scissors single-use :
  • ,
  • Surgical scrub brush single-use :
  • ,
  • Suturing needle holder single-use :
  • ,
  • Dressing/utility forceps tweezers-like single-use :
Shape Memory Medical Inc807 Aldo Avenue Suite 109

Santa Clara
CA 95054

United States

It's Interventional Regulatory LimitedUK Responsible PersonAlbreda House Lydgate Lane

Sheffield
South Yorkshire S10 5FH
UK Responsible Person
England United Kingdom
04/15/202113396
  • Non-neurovascular embolization plug composite :
  • ,
  • Neurovascular embolization coil :
  • ,
  • Vascular implant detacher single-use :
Shardman Healthcare Limited2 Watergate Lane The Green Warehouse

Leicester
Leicestershire LE3 2XP

United Kingdom







10/10/20144532
  • Enema and douche devices :
Shari Jane Daniels LimitedFlat 3 Tennyson House 5-9 Culford Gardens
London
London
SW3 2SX

United Kingdom







04/11/20228065
  • Orthodontic retainer :
Sharon Patricia TamplinGowlog Farm Llancarfan

Barry
Vale of Glamorgan CF62 3AE

United Kingdom







08/25/991259
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Dental veneer professional :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Root canal post custom-made :
Sharon Services UK ltdUnits 3 & 4 Block 20 89 Clydesmill Place
Clydesmill Industrial Estate
Glasgow
G32 8RF

Scotland United Kingdom







09/03/20176200
  • Hygiene apron single-use :
  • ,
  • Surgical cap single-use :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Bed incontinence system :
  • ,
  • Resuscitator face mask single-use :
  • ,
  • First aid absorbent pad/bandage :
  • ,
  • Multi-purpose surgical skin adhesive tape :
  • ,
  • Skin topical coupling gel :
  • ,
  • Lice treatment solution natural :
  • ,
  • Woven gauze pad non-sterile :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • First aid kit non-medicated single-use :
  • ,
  • Hand/finger splint reusable :
  • ,
  • Sterilization packaging single-use :
  • ,
  • Hot/cold therapy pack reusable :
  • ,
  • Limb tourniquet manual reusable :
  • ,
  • Hot/cold therapy pack single-use :
  • ,
  • Eye wound dressing synthetic :
  • ,
  • Oral care swab :
  • ,
  • Dry skin moisture barrier dressing :
  • ,
  • Synthetic-polymer liquid barrier dressing non-sterile :
  • ,
  • Skin-cleaning wipe non-sterile :
Sharp AestheticsUnit 3 Brookhouse Business Park Brunel Road Hadleigh Road Industrial Estate

Ipswich
Suffolk IP2 0EF

United Kingdom







02/28/20123439
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Teeth whitening tray :
  • ,
  • Custom-made mouthguard :
SharpTx Ltd44 Roseneath Road
London
London
SW11 6AQ

England United Kingdom







05/19/202214772
  • Cognitive assessment software :
Sheathing Technologies Inc.675 Jarvis Drive

Morgan Hill CA
95037

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
07/27/202116260
  • Body-orifice ultrasound imaging transducer cover basic non-sterile :
  • ,
  • Body-surface ultrasound imaging transducer cover :
  • ,
  • Intraoperative ultrasound imaging transducer cover :
  • ,
  • Body-orifice ultrasound imaging transducer cover basic :
  • ,
  • Topical coupling gel sterile :
  • ,
  • Body-surface ultrasound imaging transducer cover :
Sheffield Orthodontic Laboratories Limited550 Oxford St

Sheffield
S Yorks S6 3FG

England United Kingdom
01142662654
sol.ltd@btconnect.com






01/24/202222314
  • Custom-made mouthguard :
  • ,
  • Orthodontic archwire :
  • ,
  • Orthodontic archwire protection sleeve :
  • ,
  • Orthodontic palate expander screw bonded :
  • ,
  • Orthodontic habit prevention/breaking appliance bonded :
  • ,
  • Orthodontic habit prevention/breaking appliance self-removable :
  • ,
  • Orthodontic metal band :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic spring :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic palate expander screw self-removable :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Partial denture :
  • ,
  • Orthodontic appliance positioning tray :
  • ,
  • Orthodontic chin cap/cup :
  • ,
  • Orthodontic face bow :
Sheffmed Limited38- 40 Clifton Street

Sheffield
South Yorkshire S9 2DQ

England United Kingdom
0114 261 7161
sonia@sheffmed.com






07/14/20176297
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • ENT soft-tissue cutting forceps :
  • ,
  • Mouth gag support single-use :
  • ,
  • Ear speculum single-use :
  • ,
  • Mouth gag adjustable single-use :
  • ,
  • Hand-held surgical retractor single-use :
  • ,
  • Mouth gag support reusable :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Tongue depressor surgical :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Nasal speculum reusable :
  • ,
  • Ear speculum reusable :
  • ,
  • Tongue depressor examination single-use :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like single-use :
  • ,
  • Laryngeal mirror single-use :
  • ,
  • Surgical soft-tissue manipulation forceps alligator single-use :
  • ,
  • Ear scissors reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Laryngeal mirror reusable :
  • ,
  • ENT probe reusable :
  • ,
  • Ear speculum single-use :
  • ,
  • Nasal speculum single-use :
  • ,
  • Cast cutting scissors :
  • ,
  • Cast cutting shears :
  • ,
  • Cast spreader reusable :
  • ,
  • ENT probe single-use :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Surgical soft-tissue manipulation forceps alligator single-use :
  • ,
  • Dressing/utility forceps scissors-like single-use :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like single-use :
  • ,
  • General-purpose syringe/needle :
  • ,
  • Ear canal suction handle :
  • ,
  • Intrauterine cannula single-use :
  • ,
  • Ear scissors single-use :
  • ,
  • Tracheal surgery dilator single-use :
  • ,
  • Cast/plaster knife :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Tongue depressor examination single-use :
  • ,
  • ENT probe single-use :
  • ,
  • Dental Instruments (Re-Usable & Non-Powered) :
  • ,
  • Umbilical Clamps :
  • ,
  • Tubes (Oesophageal/Rectal) And Accessories :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Pre-Operative Devices (Razor/Marker Pen) :
  • ,
  • Surgical Instrument Accessories :
  • ,
  • Accessories For Implantable Devices (Non-Invasive) :
  • ,
  • Syringes (Hypodermic/Oral/Irrigation) :
  • ,
  • Tracheostoma protector single-use :
  • ,
  • Tracheostoma shower shield :
  • ,
  • Tracheostoma protector single-use :
  • ,
  • Stomal appliance skin-adherent patch :
  • ,
  • Personal device holder single-use :
  • ,
  • Tracheostoma shower shield :
  • ,
  • Stomal appliance skin-adherent patch :
  • ,
  • Airway device cleaning utensil invasive :
  • ,
  • Tracheostoma protective filter :
  • ,
  • Head-worn fibreoptic light :
SHENB Co. Ltd.SHENB Bldg. 148 Seongsuiro Seongdong-gu

Seoul
4796

South Korea

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

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/01/202222383
  • Microwave diathermy treatment system :
  • ,
  • Acupuncture electrical stimulation system :
  • ,
  • Nitrogen plasma skin surface treatment system :
  • ,
  • Radio-frequency skin surface treatment system :
  • ,
  • Radio-frequency skin surface treatment system :
Shenyang Bokan Biotechnology Co. Ltd.Gate 1 No. 33-22 Punan Road Shenbei New District Shenyang

Liaoning Province
110000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
11/11/202120036
  • Evacuated blood collection tube IVD no additive :
  • ,
  • Evacuated blood collection tube IVD clot activator :
  • ,
  • Evacuated blood collection tube IVD clot activator/separator :
  • ,
  • Evacuated blood collection tube IVD antiglycolytic :
  • ,
  • Evacuated blood collection tube IVD anticoagulant/separator :
  • ,
  • Evacuated blood collection tube IVD anticoagulant :
Shenzen Sunflower LaboratoryRM 1502-A EASEY COMM BLDG 253-261 HENNESSY RD WANCHAI

HONG KONG
999777

China

M-dens LTDUK Responsible Person2 CLIFTON ROAD

LOSSIEMOUTH
MORAYSHIRE IV31 6DJ
UK Responsible Person
Scotland United Kingdom
09/29/202226209
  • Dental bridge metal-ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge polymer :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Root canal post custom-made :
  • ,
  • Partial denture :
Shenzhen Acurio Instrument Co. Ltd.502G Part B Donglian Buliding Chuangye 2nd Road 23rd Subdistrict
Baoan District
Shenzhen
518000

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
12/08/202120381
  • Pulse oximeter :
Shenzhen Aeon Technology Co. Ltd.RM6H02 Block 27-29 Tianxia IC Industrial Park Majialong No.133 of Yiyuan road Nantou Street Nanshan District Shenzhen PEOPLE'S REPUBLIC OF CHINA

Shenzhen
518052

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
04/15/202213303
  • Foetal Doppler system :
  • ,
  • Infrared patient thermometer skin :
  • ,
  • Nebulizing system delivery set reusable :
  • ,
  • Pulse oximeter :
Shenzhen Antmed Co. Ltd.18 Jinhui Ave

Shenzhen
Pingshan New District 518122

China

Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202222233
  • Angiographic syringe :
  • ,
  • Catheter-tip transducer pressure :
  • ,
  • Coronary angioplasty balloon catheter perfusing :
  • ,
  • Radiographic procedure tubing :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • Catheter-exchange guidewire holder :
  • ,
  • Catheter/overtube balloon inflator single-use :
Shenzhen AOJ Medical Technology Co. Ltd.Room 301&4F Block A Building A Jingfa Intelligent Manufacturing Park
Xiaweiyuan Gushu Community Xixiang Street Bao'an District
Shenzhen
518126

China

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

Walsall
West Midlands WS1 1NS
UK Responsible Person
England United Kingdom
12/13/202120556
  • Infrared patient thermometer ear :
  • ,
  • Foetal Doppler system :
  • ,
  • Intermittent electronic patient thermometer :
  • ,
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
  • ,
  • Pulse oximeter :
Shenzhen Astec Technology Co Ltd8E Xin Bao Yi Industrial Bld Hou Ting Village
Bei Ting Road
Shenzhen
Shajing 518104

China

connie@szastec.com
Medimap LtdUK Responsible Person2 The Drift

Thurston
Suffolk IP31 3RT
UK Responsible Person
United Kingdom
04/15/202215087
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
Shenzhen Beacon Display Technology Co. Ltd.15F Building 6 Hengda Shishang Huigu(East) Fulong Road Henglang Community Dalang street Longhua Shenzhen

Guangdong Province
518109

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
11/18/202120082
  • Image display unit colour :
  • ,
  • Endoscopic video image display unit :
  • ,
  • Image display unit monochrome :
Shenzhen Belter Health Measurement and Analysis Technology Co. Ltd.702/704 Block C Tsinghua Unis Science Park No.13 Langshan Rd
Hi-Tech Industrial Park (north) Nanshan District
Shenzhen
518057

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
09/02/202117247
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
  • ,
  • Infrared patient thermometer ear/skin :
SHENZHEN BEYOND & BX DENTAL LABORATORY CO.LTD5F B-A Yicheng Industry Tiegang Village Xixiang Street
Baoan
Shenzhen
0

China

AAA DENTALAB LTDUK Responsible Person1st Floor Unit 4 Watling Gate 297-303 Edgware Road

London
NW9 6NB
UK Responsible Person
England United Kingdom
04/16/202113484
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Custom-made dental anatomy model :
  • ,
  • 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 occlusal splint custom-made :
  • ,
  • Ceramic dental inlay :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental base plate :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental impression tray single-use :
  • ,
  • Gold dental inlay :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Resin dental inlay :
  • ,
  • Partial denture :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic retainer :
  • ,
  • Fluoride gel tray :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implantation drilling template custom-made :
Shenzhen Boon Medical Supply Co. Ltd.No.18 Jirong Road Shenkeng Henggang Street Longgang District

Shenzhen
518173

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
05/17/202114703
  • Angiography kit :
Shenzhen Boon Medical Supply Co. Ltd.No.18 Jirong Road Shenkeng Henggang Street
Longgang District
Shenzhen
518173

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
09/28/202117924
  • Angiography kit :
Shenzhen BSX Technology Electronics Co. Ltd.Rm101 2/F~4/F Building No.13 Ailian Industrial park Wulian Community
Longgang District
Shenzhen Guangdong
518116

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
01/23/202222256
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
Shenzhen Caremed Medical Technology Co. Ltd.East Side 3/F C Building Kelunte Low-Carbon Industrial Park Gaofeng Community Dalang Office Longhua District Shenzhen

Guangdong Province
518109

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
06/30/202115643
  • Electrocardiographic lead set reusable :
  • ,
  • Electrocardiographic lead set single-use :
  • ,
  • Electrode/transducer strap single-use :
  • ,
  • Electrode/transducer strap reusable :
  • ,
  • Ambulatory monitoring/recording system transceiver/cable :
  • ,
  • Limb tourniquet manual reusable :
  • ,
  • Limb tourniquet manual single-use :
  • ,
  • Pulse Co-oximeter probe reusable :
  • ,
  • General-purpose patient temperature probe single-use :
  • ,
  • General-purpose patient temperature probe reusable :
  • ,
  • Pulse Co-oximeter probe single-use :
  • ,
  • Blood pressure cuff single-use :
  • ,
  • Blood pressure cuff reusable :
Shenzhen Carewell Electronics Co. LtdFloor 4 BLD 9 Baiwangxin High-Tech Industrial Park Songbai Road Xili Street Nanshan District

Shenzhen
Guangdong 518108

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
09/23/202117756
  • Cardiology information system application software :
  • ,
  • Electrocardiograph professional multichannel :
  • ,
  • Electrocardiographic long-term ambulatory recording analyser :
Shenzhen Changke Connect Electronics Co. Ltd.A2-4th floor of factory building No.87 of Hengping Road Baoan Community Yuanshan Street
Longgang District
Shenzhen
518115

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
08/17/202116833
  • Pulse oximetry telemetric monitoring system :
  • ,
  • General-purpose patient temperature probe reusable :
  • ,
  • General-purpose patient temperature probe single-use :
  • ,
  • Electrocardiographic lead set single-use :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Blood pressure cuff reusable :
  • ,
  • Neurophysiologic monitoring system :
Shenzhen Changke Connect Electronics Co. Ltd.A2-4th floor of factory building No.87 of Hengping Road
Baoan Community Yuanshan Street Longgang District
Shenzhen Guangdong
518115

China
+86(755)86159509
duansl@szcklt.com
Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
06/08/202224798
  • General-purpose patient temperature probe single-use :
  • ,
  • General-purpose patient temperature probe reusable :
  • ,
  • Patient monitoring system module pulse oximetry :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Blood pressure cuff reusable :
Shenzhen Changkun Technology Co. Ltd.201 Floor 1 & 3-8 Building B 69 Zhenbi Road
Biling Community Biling Subdistrict Pingshan District
Shenzhen
Guangdong 518118

China

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

Walsall
West Midlands WS1 1NS
UK Responsible Person
England United Kingdom
05/20/202114844
  • Infrared patient thermometer skin :
  • ,
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
Shenzhen Changkun Technology Co. Ltdt 201 Floor1&3-8 Building B 69 Zhenbi Road Biling Community Biling Subdistrict Pingshan Distric
1 Birmingham Drive
Shenzhen
Guangdong 518118

China

Easycheap ltdUK Responsible Person1 Birmingham drive Broughton

Aylesbury
HP22 7AG
UK Responsible Person
England United Kingdom
09/15/202226008
  • Automatic-inflation electronic sphygmomanometer non-portable :
Shenzhen Comen Medical Instruments Co. Ltd.Floor 10 Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2 FIYTA Timepiece Building Nanhuan Avenue Matian Sub-district Guangming District

Shenzhen Guangdong
518106

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202214704
  • Electrocardiograph professional multichannel :
  • ,
  • Electrocardiograph professional single-channel :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Centralized patient monitor :
  • ,
  • Multiple physiological parameter spot-check system clinical :
  • ,
  • Neonatal multi-parameter bedside monitor :
  • ,
  • Infrared patient thermometer ear :
  • ,
  • Anaesthesia workstation gas scavenger :
  • ,
  • General utility supply system ceiling-mounted :
  • ,
  • Pulmonary resuscitator pneumatic reusable :
  • ,
  • Infant warmer :
  • ,
  • Heated respiratory humidifier :
  • ,
  • General-purpose light source :
  • ,
  • Medical gas pipeline system :
  • ,
  • Bedside infusion pump single-channel :
  • ,
  • Neonatal intensive-care ventilator :
  • ,
  • Oxygen/air breathing gas mixer hospital :
  • ,
  • Conventional infant incubator :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Foetal cardiac monitor :
  • ,
  • Bedside syringe pump :
  • ,
  • Anaesthesia workstation general-purpose :
  • ,
  • Physiologic-monitoring defibrillation system :
  • ,
  • Central venous catheter navigation system electrocardiographic :
  • ,
  • Overhead infant phototherapy unit :
  • ,
  • Sequential venous compression system pump :
  • ,
  • Video intubation laryngoscope blade :
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • General-purpose intensive-care ventilator :
  • ,
  • Transport electric ventilator :
  • ,
  • Flexible video intubation laryngoscope reusable :
  • ,
  • Neonatal bed :
  • ,
  • Universal operating table electrohydraulic :
  • ,
  • Circulating-fluid whole-body heating/cooling system control unit :
Shenzhen CoreRay Technology Co. Ltd.5F Building 10 Huangbeiling Jingxuan Industrial Park Yousong Community Longhua Street
Longhua District
Shenzhen Guangdong
518109

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
11/08/202226859
  • Pulse oximeter probe reusable :
  • ,
  • Video intubation laryngoscope handle/monitor :
Shenzhen Creative Industry Co. Ltd.Floor 5 BLD 9 Baiwangxin High-Tech Industrial Park Songbai Road Xili Street Nanshan Distric

Shenzhen
518110

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
04/15/202222802
  • Electrocardiograph home-use :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Pulse oximeter probe reprocessed :
  • ,
  • Multiple physiological parameter spot-check system clinical :
  • ,
  • Multiple vital physiological parameter monitoring system clinical :
  • ,
  • Centralized patient monitor :
  • ,
  • Pulse oximeter :
Shenzhen Dakewe Bio-engineering Co. Ltd.Room 702-703 Building No.1 Shenzhen Biomedicine Innovations Industrial Park No.14 Jinhui Road Kengzi Street Pingshan District

Shenzhen Guangdong
518122

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202223766
  • General specimen container IVD additive/medium :
  • ,
  • General specimen collection kit IVD clinical :
Shenzhen Denco Medical Co. Ltd.Room 301 No. 8 1st road of Xiawei Industrial Zone Zhangkengjing Community Guanhu Street
Longhua District
Shenzhen
518110

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
10/24/202226722
  • Rotary/reciprocating endodontic file/rasp single-use :
Shenzhen Denco Medical Co. LtdRoom 301 No. 8 1st road of Xiawei Industrial Zone Zhangkengjing Community Guanhu Street
Longhua District
Shenzhen
518110

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
07/01/202225112
  • Rotary/reciprocating endodontic file/rasp single-use :
  • ,
  • Medical ruler reusable :
Shenzhen Dongdixin Technology Co. Ltd.Floor 1-2 No.3 Building Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District

Shenzhen
518108

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
04/15/202216243
  • Physical therapy ultrasound system :
  • ,
  • Physical therapy ultrasound/neuromuscular stimulation system :
  • ,
  • Infrared patient thermometer ear/skin :
  • ,
  • Physical therapy transcutaneous neuromuscular electrical stimulation system :
  • ,
  • Short-wave diathermy treatment system professional :
  • ,
  • Musculoskeletal/physical therapy laser professional :
  • ,
  • Electromyograph :
  • ,
  • Skin topical coupling gel :
  • ,
  • Electronic thermometer probe cover :
  • ,
  • Transcutaneous electrical stimulation electrode reusable :
  • ,
  • Pelvic floor muscle exerciser :
  • ,
  • Perineal orifice incontinence-control electrical stimulator electrode :
  • ,
  • Biofeedback system application software :
Shenzhen Dymind Biotechnology Co.Ltd.10th Floor Building B High-tech Park GuangqiaoRoad Tianliao Community Yutang Street Guangming District Shenzhen 518107 P.R. China

Shenzhen
518107

China

PureUKCA LtdUK Responsible Person59 St. Martin's Lane

London
Middlesex WC2N 4JS
UK Responsible Person
England United Kingdom
04/14/202219993
  • Non-blood cell primer/calibrator/control material IVD reagent :
  • ,
  • Full blood count IVD reagent :
  • ,
  • Serum amyloid A IVD control :
  • ,
  • C-reactive protein (CRP) IVD kit nephelometry/turbidimetry :
  • ,
  • Serum amyloid A IVD calibrator :
Shenzhen Dymind Biotechnology Co.Ltd.10th Floor Building B High-tech Park GuangqiaoRoad Tianliao Community Yutang Street Guangming District Shenzhen 518107 P.R. China

Shenzhen
518107

China

PureUKCA LtdUK Responsible Person59 St. Martin's Lane

London
Middlesex WC2N 4JS
UK Responsible Person
England United Kingdom
04/14/202219994
  • Multiple clinical chemistry analyser IVD laboratory :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory semi-automated :
  • ,
  • Full blood count IVD calibrator :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Haematological cell analyser IVD :
  • ,
  • Full blood count IVD reagent :
Shenzhen Dymind Biotechnology Co.Ltd.10th Floor Building B High-tech Park GuangqiaoRoad Tianliao Community Yutang Street Guangming District Shenzhen 518107 P.R. China

Shenzhen
518107

China

PureUKCA LtdUK Responsible Person59 St. Martin's Lane

London
Middlesex WC2N 4JS
UK Responsible Person
England United Kingdom
04/14/202219995
  • Instrument/analyser cleaning agent IVD :
  • ,
  • Multiple clinical chemistry analyser IVD laboratory :
  • ,
  • C-reactive protein (CRP) IVD calibrator :
  • ,
  • Full blood count IVD control :
Shenzhen Dymind Biotechnology Co.Ltd.10th Floor Building B High-tech Park GuangqiaoRoad Tianliao Community Yutang Street Guangming District Shenzhen 518107 P.R. China

Shenzhen
518107

China

PureUKCA LtdUK Responsible Person59 St. Martin's Lane

London
Middlesex WC2N 4JS
UK Responsible Person
England United Kingdom
04/14/202219996
  • C-reactive protein (CRP) IVD control :
  • ,
  • Serum amyloid A IVD kit nephelometry/turbidimetry :
  • ,
  • Blood cell lysis reagent IVD :
Shenzhen Enmind Technology Co. Ltd.Room 201 Block A No.1 Qianhai Road 1 Qianhaishen Port Cooperative District

Shenzhen
Guangdong 518101

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
06/21/202225015
  • Infrared-light vein locator :
  • ,
  • Medical equipment clinical data interfacing software :
Shenzhen Envisen Industry Co. Ltd.Block 1  Room 201  301  401  40 Jianlong  Street Baoan Community  Yuanshan Town Longgang District

Shenzhen
Guangdong 518115

China

Neoventa Medical Ltd UK Responsible Person34 Anyards Road

Cobham
Surrey KT 11 2LA
UK Responsible Person
England United Kingdom
regulatory@neoventa.com
11/05/202119852
  • Pulse oximeter probe reusable :
Shenzhen Everbest Machinery lndustry Co. Ltd.19th Building 5th Region Baiwangxin lndustrial Park Songbai Rd. Baimang Xili Nanshan

Shenzhen
518108

China

lotus global co ltdUK Responsible Person23 Maine Street

Reading
Reading RG2 6AG
UK Responsible Person
England United Kingdom
04/13/202216185
  • Infrared patient thermometer ear/skin :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory :
Shenzhen Finicare Co. Ltd.201 No.50 the 3rd Industrial Park Houting Community Shajing Street
Bao'an District
Shenzhen
518104

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
03/03/202223366
  • Infrared patient thermometer skin :
Shenzhen Fitconn Technology Co. Ltd.7th Floor No.116 Xiangshan Road Luotian Community
Songgang Street Bao'an
Shenzhen Guangdong
518105

China

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

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
10/07/202118118
  • Benchtop nebulizer non-heated :