Manufacturer's By Device SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid-SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, immunochromatographic test (ICT), rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Beijing Hotgen Biotech Co Ltd9th Building No 9 Tianfu Street Biomedical Base Daxing District

Beijing
102600

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
02/27/202112377
Coris BioConceptScience Park CREALYS Rue Jean Sonet 4A

Gembloux
5032

Belgium
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom
07/09/202115819
Healvet Medtech GZ LtdB201 Building 2 No.6 Xinrui Road Hi-Tech Industrial Development Zone

Guangzhou
51000

China
HUA TENG LIMITED3 Glass Street Hanley

Stoke On Trent
ST1 2ET

England United Kingdom
05/10/202114559
Omega Diagnostics LimitedOmega House Hillfoots Business Village

Alva
Clackmannanshire FK12 5DQ

United Kingdom





10/20/201624
Shenzhen Microprofit Biotech Co. LtdRm. 405 406 Zone B /4F Rm. 205 206-1 207 West Side of Zone B/ 2F Haowei Building No. 8 Langshan 2nd Road
Songpingshan Songpingshan Community Xili Street Nanshan District
Shenzhen
518057

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/19/202112785
Shenzhen YHLO Biotech Co. Ltd.Building 1 YHLO Biopark Baolong 2nd Road Baolong Subdistrict Longgang District

Shenzhen Guangdong
518116

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/30/202011290