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 LtNo 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. LTD4th Floor D-1# Zone Pearl Industrial Park 106 Innovation Avenue High-Tech Development Zone

Hefei
Anhui 230088

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202212384
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 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
05/10/202217955
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
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
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
Hangzhou Laihe Biotech Co. Ltd1st Floor Room 505-512

Zhejiang
310052

China
Intamarca LLPThe Manor House 16 Main Street
Long Lawford Rugby
Rugby
Warwickshire CV23 9AZ

England United Kingdom
03/13/202112632
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
Mornington 2000 LLP trading as Sterilab Services18 Mornington Terrace

Harrogate
North Yorkshire HG1 5DH

England United Kingdom
08/18/202116754
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