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

SARS-CoV-2 immunoglobulin G (IgG)/IgM/neutralizing 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 137997. The device is manufactured by Hoyotek Biomedical Co. Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is QAdvis UK 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.

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

MHRA Device ID: 137997•Ref: 137997

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Feb 24, 2022

Last Updated

Nov 7, 2023

Manufacturer Information

Name

Hoyotek Biomedical Co. Ltd.

Address

Floor 4, Zone C, Workshop No. 1, China Civil Aviation Science and Technology Industrialization Base No. 225 Jinger Road, Tianjin Airport Economic Zone

Tianjin, China

Created Date

Feb 24, 2022

Authorized Representative

Name

QAdvis UK Ltd

Relationship Type

UK Responsible Person

Address

55-66 Frederick Street

Edinburgh, EH2 1LS, Scotland, United Kingdom

Postcode: EH2 1LS

DJ Fang

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

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