SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 134496. The device is manufactured by Kangmei Tianhong Biotech (Beijing) 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.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 134496•Ref: 134496

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 17, 2023

Manufacturer Information

Name

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Address

#16, No.1 Gaolizhang Road,

Haidian, Beijing, China

Created Date

Dec 16, 2021

Authorized Representative

Name

Wellkang Ltd

Relationship Type

Authorised Representative (Northern Ireland)

Address

Enterprise Hub, NW Business Complex 1 Beraghmore Road

Derry, Northern Ireland, Northern Ireland, United Kingdom

Postcode: BT48 8SE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Kangmei Tianhong Biotech (Beijing) Co., Ltd. (6)

Other Products from Same Authorized Representative (10)

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Nucleic acid extraction/isolation kit IVD

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

General specimen container IVD, no additive/medium

SARS-CoV-2/influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid

Dental/surgical polymerization lamp

Haematological cell analyser IVD

Haemoglobin analyser IVD, laboratory

Glucose analyser IVD, home-use

Reticulocyte count IVD, control

Intravenous access site protector

Knee support orthosis

Medicine cup, single-use

Haemoglobin detection IVD, reagent

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)