Faecal occult blood IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration
Faecal occult blood IVD, kit, rapid ICT, self-testing is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 146129. The device is manufactured by NewScen Coast Bio-Pharmaceutical Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Device Type
In Vitro Diagnostic Device
Devices
Faecal occult blood IVD, kit, rapid ICT, self-testing
Type
IVD Devices for Self-Testing
Date Registered
Nov 26, 2024
Last Updated
May 26, 2024
Address
No. 65, 6th Street, Tianjin TEDA,
Tianjin, China
Created Date
Sep 18, 2020
Name
Wellkang LtdRelationship Type
Address
Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE
Clostridium difficile antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Multiple Salmonella species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Interleukin-6 (IL-6) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Prolactin IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Total human chorionic gonadotropin IVD, reagent
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered sample diluent IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Ferritin IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple anti-neutrophil cytoplasmic antibody/glomerular basement membrane antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Leg procedure positioner
Type: General Medical Device
Manufacturer: Opitek International
Leg sling
Type: General Medical Device
Manufacturer: Opitek International
Vision training software
Type: General Medical Device
Manufacturer: Guangzhou Shijing Medical Software Co., Ltd.
Surgical gown, single-use
Type: General Medical Device
Manufacturer: Haian Medigauze Co., Ltd.
Penile vacuum device
Type: General Medical Device
Manufacturer: BonRoux Pty Ltd
Surgical/medical face mask, single-use
Type: General Medical Device
Manufacturer: BYD Precision Manufacture Co., Ltd.
Inspiratory line humidification chamber, single-use
Type: General Medical Device
Manufacturer: Oxytek Medical Technology Co., Ltd.
Microbiological transport medium IVD
Type: In Vitro Diagnostic Device
Manufacturer: Merah Medical Sdn Bhd.
Ice bag
Type: General Medical Device
Manufacturer: The Hilsinger Company Parent, LLC dba Bruder Healthcare
Freestanding patient lifting system, electrically-powered
Type: General Medical Device
Manufacturer: Opitek International

