Manufacturer's By Device SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing-SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
ACON Biotech (Hangzhou) Co LtNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
02/10/202111766
Acon Laboratories Inc.5850 Oberlin Drive #340

San Diego CA
92121

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
04/07/202113082
Anbio (Xiamen) Biotechnology Co. Ltd.No.2016 Wengjiao West Road Xinyang Street Haicang District 361026 Xiamen Fujian China

Xiamen
361026

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
10/20/202118903
Beijing Lepu Medical Technology Co. LtdBuilding 7-1 No.37 Chaoqian Road Changping District

Beijing
102200

China
My DNA Holdings Ltd.18 School Road

Reepham
Norfolk NR10 4JP

United Kingdom
10/11/202117955
Excalibur Healthcare Services Ltd.60 St. James's Street

London
SW1A 1LE

England United Kingdom





12/31/999911885
Getein BiotechNo 9 Bofu Road

Nanjing
Luhe District 211505

China
UKOS LtdUnit 6 Boundary Way

Hemel Hempstead
Hertfordshire HP2 7TE

England United Kingdom
08/11/202116747
Guangzhou Wondfo Biotech Co. Ltd.No.8 Lizhishan Road Science City Luogang District

Guangzhou
510663

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/07/202112536
Hangzhou Alltest Biotech Co Ltd#550 Yinhai Street Hangzhou Economic & Technological Development Area

Hangzhou
310018

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
03/28/202112580
Healgen Scientific Limited3818 Fuqua Street

Houston
TX 7707

United States
SENSUS Group LtdThe Barn Tednambury Farm
Tednambury
Spellbrook
Hertfordshire CM23 4BD

England United Kingdom
06/17/202115437
MP Biomedicals Germany GmbHThüringer Straße 15

Eschwege
37269

Germany
Mornington 2000 LLP trading as Sterilab Services18 Mornington Terrace

Harrogate
North Yorkshire HG1 5DH

England United Kingdom
08/18/202116754
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
Shenzhen Kisshealth Biotechnology Co. Limited301 Building B No. 16-1 Jinhui Road
Jinsha Community Kenzi Sub-district Office Pingshan District
Shenzhen
518118

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

England United Kingdom
02/12/202112118
Sugentech Inc.721-26 Jeongjungyeonje-ro Osong-eup Heungdeok-gu

Cheongju-si
Chungcheongbuk-do 28161

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
07/07/202115729
Zhejiang Orient Gene Biotech Co. Ltd3787# East Yangguang Avenue Dipu Street
Anji Huzhou
Zhejiang
3787

China
SENSUS Group LtdThe Barn Tednambury Farm
Tednambury
Spellbrook
Hertfordshire CM23 4BD

England United Kingdom
09/14/202117510