Manufacturer's By Device Glycated haemoglobin (HbA1C) analyser IVD-Glycated haemoglobin (HbA1C) analyser IVD, Glycated haemoglobin (HbA1C) analyser IVD Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
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
Bio-Rad Laboratories Inc. Clinical Systems Division (CSD)4000 Alfred Nobel Drive

Hercules
94547

United States
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202221626
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
EKF-diagnostic GmbHEbendorfer Chaussee 3

Barleben
D-39179

Germany
EKF Diagnostics Holdings plcAvon House 19 Stanwell Road
Penarth
Cardiff
CF64 2EZ

Wales United Kingdom
12/21/202120794
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
OSANG Healthcare Co. Ltd.132 Anyangcheondong-ro Dongan-gu

Anyang-si
Gyeonggi-do 14040

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
10/04/202117967
Primus Corporation dba Trinity Biotech Kansas CityPrimus Corporation dba Trinity Biotech Kansas City 6080 Jericho Turnpike
Suite 208
NY
Commack 11725

United States
IVDeology UKRP Ltd22-23 The Joiners Shop Historic Dockyard
Chatham
Rochester
Kent ME4 4TZ

England United Kingdom
01/18/202221309
Shenzhen Lifotronic Technology Co. Ltd.Unit A 4th Floor Building 15 Yijing Estate No.1008 Songbai Road Nanshan District

Shenzhen
518055

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
04/14/202220803
Siemens Healthcare Diagnostics Inc511 Benedict Avenue

Tarrytown
NY 10591

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201534
Tosoh CorporationShiba-koen First Bldg. 3-8-2 Shiba Minato-ku

Tokyo
105-8623

Japan
Tosoh Bioscience LimitedLytchett House Wareham Road
13 Freeland Park
Poole
Dorset BH16 6FA

England United Kingdom
04/27/202215586
Wuxi BioHermes Bio & Medical Technology Co. Ltd.No. 136 Mashan Meiliang Road Binhu

Wuxi
Jiangsu 214092

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
09/12/202217961
Wuxi BioHermes Bio & Medical Technology Co. Ltd.No. 136 Mashan Meiliang Road Binhu

Wuxi
Jiangsu 214092

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
09/12/202217961