Manufacturer's By Device SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical-SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Rapid Diagnostics Jena GmbHOrlaweg 1

Jena
Thuringia 07743

Germany
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
03/15/202112662
Abiores Technology (Beijing) Co. Ltd.No.8 Central Road Doudian Town
Fangshan District
Beijing
102433

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/12/202224169
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
Acro Biotech Inc.4650 Arrow Highway Suite D-6

Montclair
CA 91763

United States
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
04/26/202113601
Aikang Diagnostics Co Ltd.501 Building 1&3 Hongxin Industrial Park
Guanguang Road 1303 Guanlan Longhua District
Guangdong
Shenzhen 518110

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202216334
Asan Pharmaceutical Co. Ltd.122-26 Gieopdanji-ro Gongdo-eup

Anseong-si
Gyeonggi-do 17551

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

Oxford
OX1 2EP

England United Kingdom
07/12/202225236
Atlas Medical GmbHLudwig-Erhard-Ring 3 15827 Blankenfelde-Mahlow

Berlin
15827

Germany
Atlas MedicalWilliam James House Cowley Road

Cambridge
CB4 0WX

United Kingdom
04/21/202113630
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
Bionote Inc.22 Samsung 1-ro 4-gil

Hwaseong-si
Gyeonggi-do 18449

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

Oxford
OX1 2EP

England United Kingdom
06/22/202115246
ChemBio Diagnostic System Inc555 Wireless Boulevard Hauppauge

New York
11788

United States
Luas Diagnostics40 Occam Road

Guildford
Surrey GU2 7YG

England United Kingdom
03/23/202212577
ChemBio Diagnostic System Inc555 Wireless Boulevard Hauppauge

New York
11788

United States
Luas Diagnostics40 Occam Road

Guildford
Surrey GU2 7YG

England United Kingdom
03/23/202212577
CIGA Healthcare Ltd27 Kildowney Road
Kilcran House
Ballymena
BT44 9EY

Northern Ireland United Kingdom





05/28/20096864
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
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
DxGen Corp.Rm. 303-1 and Rm. 510 172 LS-ro

Gunpo-si
Gyeonggi-do 15807

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

Oxford
OX1 2EP

England United Kingdom
11/29/202117714
e-LinkCare Meditech Co. Ltd.No.30 Baita Tongjiang Road

Taizhou Zhejiang
317317

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
09/01/202010509
Edinburgh Genetics Limited64a Cumberland Street

Edinburgh
EH3 6RE

Scotland United Kingdom
EG GENETICS LIMITEDMoat House 54 Bloomfield Ave

Belfast
BT5 5AD

Northern Ireland United Kingdom
04/15/202211340
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 Genesis Biodetection and Biocontrol Co. Ltd.No.139 10th Street (East) Hangzhou Economic & Technological Development Zone

Zhejiang Province
310108

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
05/20/202114802
Inzek International Trading BVVissenstraat 32

Apeldoorn
Provincie Gelderland 7324 AL

Netherlands
Dawn Asset Management LimitedKalamu House Coldbath Square

London
EC1R 5HL

England United Kingdom
04/20/202216090
Jiangsu Konsung Bio-Medical Science And Technology Co. Ltd.No. 8 Shengchang West Road Danyang Development Zone

Jiangsu Province
212300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/29/202119036
Jiangsu Swirl Medical Technology Co. LTD2F Building 1 Electronic Industrial Park No.9 Xindong Road Economic and Technological Development Zone

Nantong
Jiangsu Province 226000

China
MedPath Limited27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom
04/21/202112931
Kangmei Tianhong Biotech (Beijing) Co. Ltd. #16 No.1 Gaolizhang Road

Haidian Beijing
100095

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
01/10/202221131
Lifeassay Diagnostics (Pty) Ltd7 Bell Crescent Westlake Business Park

Cape Town
7945

South Africa
TNMC Medical Devices Ltd910 The Crescent Colchester Business Park
Colchester
Colchester
Essex CO49YQ

England United Kingdom
03/08/202211036
MEDCAPTAIN Medical Technology Co. Ltd.12th Floor Baiwang Research Building No.5158 Shahe West Road Xili Nanshan

Shenzhen Guangdong
518055

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
02/22/202112290
Medusa 19 Life Sciences LimitedThe Innovation Centre Sci-tech Daresbury
Keckwick Lane
Daresbury
Cheshire WA4 4FS

United Kingdom





08/05/202010415
Merlin Biomedical (Xiamen) Co. Ltd.4th Floor Building B3 2054 West Wengjiao Rd.

Haicang
Xiamen 361028

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/07/202113061
MiCo BioMed Co. Ltd.116 Gongdan 1-ro

Anseong-si
Gyeonggi-do 17575

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

Oxford
OX1 2EP

England United Kingdom
07/14/202115954
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
Nanjing Liming Bio-Products Co. Ltd.No.12 Huayuan Road

Nanjing Jiangsu
210042

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/09/202011119
NewScen Coast Bio-Pharmaceutical Co. Ltd.No. 65 6th Street Tianjin TEDA

Tianjin
300457

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/28/202210590
NewScen Coast Bio-Pharmaceutical Co. Ltd.No. 65 6th Street Tianjin TEDA

Tianjin
300457

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/28/202210590
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Prometheus Bio Inc2nd floor No. 3 8th Street Qiantang Area

Hangzhou Zhejiang
310018

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/29/202114185
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
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 JetMay Care LimitedDistrict 02 1F & 3F Block A Haikexing Sinovac Strategic Emerging Industrial Park Pingshan District

Shenzhen Guangdong
518118

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/14/202210391
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
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
Vedalabrue de l'Expansion ZAT du Londeau Cerisé rue de l'Expansion ZAT du Londeau Cerisé

ALENCON CEDEX
61006

France
First Health Products LtdOpTIC Technology Centre Glyndr University St Asaph Business Park

St Asaph
Denbighshire LL17 0JD

United Kingdom
10/14/202118160
Wuhan Life Origin Biotech Joint Stock Co. LtdFloor 1st 2nd and 3rd Wuhan Hi-Tech Medical Device Park B11 No.818 Gaoxin Avenue Donghu Hi-Tech Development Zone

Wuhan
Hubei Province 430206

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

United Kingdom
05/11/202113988
Xiamen Biotime Biotechnology Co. Ltd.2F/3F/4F/5F No.188 Pingcheng South Road Haicang District

Xiamen
Fujian 361026

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210710
Xiamen Boson Biotech Co. Ltd.90-94 Tianfeng Road Jimei North Industrial Park

Xiamen
Fujian 361021

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202210786
Zhejiang Quark Biological Technology Co. Ltd.No.1 Jiangdong Road Zhejiang Xinchang High-tech Industrial Park

Shaoxing Xinchang District Zhejiang
312500

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/30/202011214