SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 67645. 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.

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SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 67645

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

Type

IVD General

Date Registered

Feb 26, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

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

DJ Fang

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SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

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