United Kingdom MHRA device registration 67642

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

United Kingdom·In Vitro Diagnostic Device·Beijing Hotgen Biotech Co Ltd·Registered Feb 26, 2021

Registration details

Device ID: 67642
Date Registered: Feb 26, 2021
Last Updated: Dec 22, 2022

Device classification

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

Manufacturer

Name: Beijing Hotgen Biotech Co Ltd
Address: 9th Building, No 9 Tianfu Street, Biomedical Base Daxing District
Beijing, China
Created Date: Feb 26, 2021

Authorized Representative

Name: Medimap Ltd
Relationship Type: UK Responsible Person
Address: 2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT

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About this record

SARS-CoV-2 immunoglobulin A (IgA)/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 67642. The device is manufactured by Beijing Hotgen Biotech Co Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap 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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