United Kingdom MHRA device registration 137997

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

United Kingdom·In Vitro Diagnostic Device·Hoyotek Biomedical Co. Ltd.·Registered Feb 24, 2022

Registration details

Device ID: 137997
MHRA Reference Number: 137997
Date Registered: Feb 24, 2022
Last Updated: Nov 7, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 immunoglobulin G (IgG)/IgM/neutralizing antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

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

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About this record

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.

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