Manufacturer's By Device Glycated haemoglobin (HbA1c) IVD kit liquid chromatography-Glycated haemoglobin (HbA1c) IVD kit liquid chromatography

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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
Goldsite Diagnostics Inc.No. 103C 503C & 504D Technology Building & No. 3A & 4A Technology Building Annex Zhaoshang Sub-District

Nanshan District
Shenzhen 518067

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/25/202225708
SEKISUI MEDICAL CO. LTD.1-3 Nihonbashi 2-chome Chuo-ku

Tokyo
103-0027

Japan
Sekisui Diagnostics (UK) LtdSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ

England United Kingdom
12/22/202121453
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
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
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