Manufacturer's By Device Helicobacter pylori antigen IVD kit rapid ICT clinical-Helicobacter pylori antigen IVD kit rapid ICT clinical

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Korea Inc.65
Borahagal-Ro Giheung-Gu
Gyeonggi-Do
Yongin-Si 17099

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

England United Kingdom
03/30/202113027
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
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
Apacor LimitedUnit 5 Sapphire Centre

Wokingham
Berkshire RG41 2QL

United Kingdom





04/16/20157192
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
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
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
Coris BioConceptScience Park CREALYS Rue Jean Sonet 4A

Gembloux
5032

Belgium
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom
07/09/202115819
ETest (Nantong) Medical Electronic Technology CO. LtdRoom 502 Building 9 No.1 Hengke Road Qutang Town Haian City

Jiangsu Province
226661

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
09/16/202226021
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
HUMAN Gesellschaft für Biochemica und Diagnostica mbHMax-Planck-Ring 21

Wiesbaden
65205

Germany
Cambridge Life Sciences Ltd14 St. Thomas' Place

Ely
Cambridgeshire CB7 4EX

England United Kingdom
12/22/202121401
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
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
KOROGLU MEDIKAL TIBBI MALZ.KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LTD.STI.1776/23 Sokak No:4/A Mevlana Mahallesi Bornova

IZMIR
35050

Turkey
E&E MEDICAL SUPPLIES LTD.Unit 2 Fairway Business Centre Westergate Road

Brighton
Sussex BN2 4JZ

England United Kingdom
03/04/202223421
Meridian Bioscience Inc.3471 River Hills Drive

Cincinnati
OH 45244

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
09/08/202117346
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
Oxoid LimitedWade Road

Basingstoke
RG24 8PW

England United Kingdom





04/17/20157191
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
Pro-Lab Diagnostics3 Bassendale Road

Bromborough
Wirral CH62 3QL

England United Kingdom





01/16/2004958
R-Biopharm AGR-Biopharm AG An der neuen Bergstrasse 17

Darmstadt
64297

Germany
R-Biopharm Rhone LtdMazars 30 Old Bailey

London
EC4M 7AU

England United Kingdom
11/15/202120085
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
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
SENTINEL CH. S.p.A.Via Robert Koch 2
Milano
MI
Lombardia 20152

Italy
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/10/202116678
Shanghai Homelabs Medical Co. LtdRoom 301 No. 5 Lane 88 Shengrong Road China (Shanghai) Pilot Free Trade Zone.

Shanghai
201203

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

United Kingdom
05/27/202224775
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
Shenzhen Uni-medica Technology Co. LtdRoom 202 Block 6th LiuXian Culture Park XiLi Town NanShan District

Shenzhen
Guangdong Province 518000

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/17/202225540
TS Diagnostics Sdn Bhd CompanyNo. 9 Jalan TPP 5/11 Taman Perindustrian Puchong 47160 Selangor Malaysia

Selangor
47160

Malaysia
Atlas MedicalWilliam James House Cowley Road

Cambridge
CB4 0WX

United Kingdom
05/24/202224730
W.H.P.M. Bioresearch & Technology Co. Ltd.No.2 Zhongxin Street Louzizhuang Jinzhanxiang Chaoyang District

Beijing
100018

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202213234