Manufacturer's By Device Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid-Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Medical Co. Ltd.357 Matsuhidai Matsudo-shi

Chiba
270-2214

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

England United Kingdom
04/19/202113507
Abbott Toxicology Ltd21 Blacklands Way Abingdon Business Park

Abingdon
Oxfordshire OX14 1DY

United Kingdom





12/10/20199407
ABON Biopharm (Hangzhou) Co. Ltd.#198 12th Street East Hangzhou Economic & Technological Development Zone

Hangzhou
Zhejiang 310018

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

England United Kingdom
04/19/202113506
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
Assure Tech. (Hangzhou) Co. Ltd.Building 4 No. 1418-50 Moganshan Road Gongshu District

Hangzhou Zhejiang
31011

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
09/07/202116390
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
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
Bao Ruiyuan Biotech (Beijing) Co. Ltd.No.8 Central Road Doudian Town Fangshan District

Beijing
102433

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
10/06/202118024
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Care Diagnostica Produktions- und Vertriebsgesellschaft m.b.H.Roemerstrasse 8

Traiskirchen
2514

Austria
First Health Products LtdOpTIC Technology Centre Glyndŵr University St Asaph Business Park

St Asaph
Denbighshire LL17 0JD

United Kingdom
10/11/202118161
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
Core Technology Co. Ltd.Room 100 C Building No.29 Life Park Rd. Changping District

Beijing
102206

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
10/05/202118031
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
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
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
Hangzhou Sejoy Electronics & Instruments Co. Ltd.Area C Building 2 No. 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City

Zhejiang Province
311100

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
07/09/202115779
Healgen Scientific3818 Fuqua Street

Houston
Texas 77047

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

England United Kingdom
09/14/202117512
HEALTHPOINT LTD11 Darwin Court Blackpool Technology Park

BLACKPOOL
Lancashire FY2 0JN

England United Kingdom





03/25/202112922
Innovacon Inc9975 Summer Ridge Road

San Diego
California 92121

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

England United Kingdom
12/02/202120262
Matrix Diagnostics LtdMatrix Diagnostics Ltd Unit 9 Merdian Business Park Fleming Road Waltham Abbey
Waltham Abbey
Waltham Abbey
Essex EN9 3BZ

United Kingdom





12/04/20199393
Nantong Egens Biotechnology Co. Ltd.Building 15 Building 12(west) No. 1692 Xinghu Avenue Nantong Economy & Technology Development Zone

Nantong Jiangsu
226010

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
05/29/202114949
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
Snowden LimitedResearch & Innovation Centre

Nottingham
NG7 2NN

United Kingdom





02/19/20209620
SPD Swiss Precision Diagnostics GmbH47 route de Saint-Georges

Petit-Lancy
1213

Switzerland
SPD Development Company LimitedPriory Business Park

Bedford
Bedfordshire MK44 3UP

England United Kingdom
09/15/202117567
Tianjin New Bay Bioresearch Co. LtdNo. 1 Jianshe Road Ba Li Tai Industry Area
Jinnan District
Tianjin
300350

China
SYRINGA UK LTDUnit G Daux Road

Billingshurst
RH14 9SR

England United Kingdom
10/15/202118316
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 Glyndŵr University St Asaph Business Park

St Asaph
Denbighshire LL17 0JD

United Kingdom
10/14/202118160
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
Zhengzhou Fortune Bioscience Co. Ltd.Fangxin Industrial Zone Baisha Town
Zhongmou County
Zhengzhou
451464

China
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
11/07/202119572