Manufacturer's By Device SARS-CoV-2 antigen IVD kit rapid ICT self-testing-SARS-CoV-2 antigen IVD kit rapid ICT self-testing

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

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202211766
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO. LTD.4th Floor D-1# Zone Pearl Industrial Park 106 Innovation Avenue High-Tech Development Zone

Hefei
Anhui 230088

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
06/28/202225076
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO. LTD.4th Floor D-1# Zone Pearl Industrial Park 106 Innovation Avenue High-Tech Development Zone

Hefei
Anhui 230088

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
06/28/202225076
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 Wantai Biological Pharmacy Enterprise Co. Ltd.No. 31 Kexueyuan Road Changping District

Beijing
102206

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/02/202221394
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
CITEST DIAGNOSTICS INC170-422 Richards Street Vancouver BC
V6B 2Z4 Canada
Vancouver
V6B 2Z4

Canada
UK RepMed Ltd.Wey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT

England United Kingdom
08/11/202116644
CorDx Inc.9540 Waples Street Unit C

San Diego CA
92121

United States
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/29/202121573
Core Technology Co. Ltd.Room 100 C Building No.29 Life Park Rd. Changping District

Beijing
102206

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/24/202011242
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
Getein Biotech Inc.No.9 Bofu Road Luhe District

Nanjing
211505

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
02/09/202222849
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
04/15/202212580
Healgen Scientific Limited3818 Fuqua Street

Houston
TX 7707

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

England United Kingdom
05/04/202215437
MP Biomedicals Germany GmbHThueringer Strasse 15

Eschwege
37269

Germany
Sterilab Services Ltd.Unit 700 Street 5
Thorp Arch Estate
Wetherby
West Yorkshire LS23 7FZ

England United Kingdom
08/18/202116754
Nanjing Synthgene Medical Technology Co. Ltd.Building B6-2 No. 9 Weidi Road Xianlin University Town
Xianlin Subdistrict Qixia District
Nanjing
Jiangsu Province 210000

China
NPZ technology LtdStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE

United Kingdom
08/17/202225584
SAFECARE BIOTECH (HANGZHOU) CO. LTD.Building 2/203 No. 18 Haishu Rd.
Cangqian Sub-district Yuhang District
Hangzhou
311121

China
SHARE INFO LTD3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS

England United Kingdom
01/23/202222245
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
03/25/202212118
Wuhan EasyDiagnosis Biomedicine Co. Ltd.Room 3 & 4 2nd Floor Bldg 25 Phase 3.1 Wuhan Optics Valley International Biopharmaceutical Enterprise Accelerator No. 388 Gaoxin 2nd Road East Lake Hi-Tech Development Zone

Wuhan
Hubei 430074

China
Bioteck Limited1 The Green

Richmond
TW9 1PL

England United Kingdom
04/06/202213639
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
05/04/202217510
Zybio IncFloor 1 to Floor 5 Building 30 No.6 of Taikang Road Block C of Jianqiao Industrial Park Dadukou District

Chongqing
400082

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202221601