Manufacturer's By Device Single-channel clinical chemistry analyser IVD point-of-care-Single-channel clinical chemistry analyser IVD point-of-care

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Technologies ASKjelsasveien 161 P.O. Box 6863 Rodelokka

Oslo
NO-0504

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

England United Kingdom
07/29/202116309
Abbott Toxicology Ltd21 Blacklands Way Abingdon Business Park

Abingdon
Oxfordshire OX14 1DY

United Kingdom





12/10/20199407
ARKRAY Factory Inc.1480 Koji Konan-cho
Koka-shi
Shiga
520-3306

Japan
Arkray LtdBeacon House Ibstone Road
Stokenchurch Business Park
High Wycombe
Buckinghamshire HP14 3FE

England United Kingdom
08/06/202116431
ARKRAY Factory Inc.1480 Koji Konan-cho
Koka-shi
Shiga
520-3306

Japan
Arkray LtdBeacon House Ibstone Road
Stokenchurch Business Park
High Wycombe
Buckinghamshire HP14 3FE

England United Kingdom
08/06/202116431
FUJIFILM Corporation26-30 Nishiazabu 2-chome
Minato-ku
Tokyo
106-8620

Japan
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202218937
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
Nova Biomedical Corporation200 Prospect Street

Waltham
MA 02454-9141

United States
Nova Biomedical CorporationInnovation House Aston Lane South
Runcorn
Runcorn
Cheshire WA7 3FY

England United Kingdom
05/18/202217568
Roche Diagnostics GmbHSandhofer Strasse 116

Mannheim
68305

Germany
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/19/202113524
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 Watmind Medical Co. Ltd8th Floor Building A No. 16-1 Jinhui Road
Jinsha Community Kengzi Sub-District Office Pingshan District
Shenzhen
Guangdong Province 518118

China
Jump Start Consulting LimitedUnit 24 Cranfield Innovation Centre
University Way
Cranfield
Bedfordshire MK43 0BT

England United Kingdom
03/22/202112401
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201532