Manufacturer's By Device SARS-CoV-2/Influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid-SARS-CoV-2/Influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Acro Biotech Inc.9500 7th Street Unit M

Rancho Cucamonga
CA 91730

United States
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
04/26/202113601
AMS UK (NI) Limited42 Ballymena Business Centre

Ballymena
Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157209
Autobio Diagnostics Co. LtdNo. 87 Jingbei Yi Road National Eco & Tech Development Area

Zhengzhou
450016

China
Chirus LimitedGreenhill House 26 Greenhill Crescent
Watford Business Park
Watford
Hertfordshire WD18 8JA

England United Kingdom
09/01/202116792
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
Co-Innovation Biotech Co. Ltd.No.9 Baihe 3 Street Economic and Technological Development East Zone

Guangzhou
Guangdong 510530

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
03/19/202112765
Fortress Diagnostics LtdUnit 9A Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





12/31/999911557
Fortress Diagnostics3787# East Yangguang Avenue Dipu Street

Anji
Huzhou Zhejiang 313300

China
Fortress Diagnostics LtdUnit 9A Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom
01/14/202111558
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Sansure Biotech Inc.No. 680 Lusong Road Yuelu District

Changsha
Hunan Province 410205

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/28/202117610
Shanghai Cagenbio Science Co. LtdRm.320 Building 5 No.185 East Jiangtian Road Songjiang District

Shanghai
201613

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
04/21/202113354
Shenzhen Kisshealth Biotechnology Co. Ltd301 Building B No. 16-1 Jinhui Road
Jinsha Community - Kengzi Sub-District Office Pingshan District
Shenzhen
Guangdong Province 518118

China
Jump Start Consulting LimitedUnit 24 Cranfield Innovation Centre
University Way
Cranfield
Bedfordshire MK43 0BT

England United Kingdom
03/22/202112400
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