SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 68153. The device is manufactured by Guangzhou KoFa Biotechnology 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
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Sep 5, 2024
Address
5F/6F, Building C4, No.11 Kaiyuan Avenue Science City
Guangzhou City, Guangdong, China
Created Date
Mar 2, 2021
Name
Wellkang LtdRelationship Type
Address
Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
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
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen 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
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Dental occlusal splint, preformed, single-use
Type: General Medical Device
Manufacturer: Vedia solutions, Div of Laxmidental Export Pvt Ltd
Orthodontic progressive aligner
Type: General Medical Device
Manufacturer: Vedia solutions, Div of Laxmidental Export Pvt Ltd
Temporary dental crown/bridge resin
Type: General Medical Device
Manufacturer: Vedia solutions, Div of Laxmidental Export Pvt Ltd
Orthodontic progressive aligner
Type: General Medical Device
Manufacturer: Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,
Temporary dental crown/bridge resin
Type: General Medical Device
Manufacturer: Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,
Dental implant suprastructure, temporary, preformed, single-use
Type: General Medical Device
Manufacturer: Biomate Medical Devices Technology Co. Ltd.
Dental implant system
Type: General Medical Device
Manufacturer: Biomate Medical Devices Technology Co. Ltd.
Dental implant system
Type: General Medical Device
Manufacturer: Biomate Medical Devices Technology Co. Ltd.
Elbow/ankle friction/impact protector
Type: General Medical Device
Manufacturer: Walgreen Health Solutions, LLC
Dental casting non-noble alloy
Type: General Medical Device
Manufacturer: Vedia solutions, Div of Laxmidental Export Pvt Ltd

