Manufacturer's By Device Clinical laboratory analyser/instrument control unit IVD-Clinical laboratory analyser/instrument control unit IVD

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Rapid Diagnostics Jena GmbHOrlaweg 1

Jena
Thuringia 07743

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

England United Kingdom
03/15/202112662
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
Caliber Imaging and Diagnostics Inc.50 Methodist Hill Drive Suite 1000

Rochester
New York 14623

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
01/13/202221238
Diapath SpAVia Pietro Savoldini
MARTINENGO
BG
Lombardia 24057

Italy
CellPath LtdUnit 80 Mochdre Enterprise Park

Newtown
Powys SY16 4LE

United Kingdom
12/08/202120394
iLsa DiagnosticRue de la comtesse

Marchaux
F.25640

France
Pro-Lab Diagnostics3 Bassendale Road

Bromborough
Wirral CH62 3QL

England United Kingdom
08/17/202225536
Milestone SrlVia Fatebenefratelli 1/5 Sorisole

BG
24010

Italy
A. Menarini Diagnostics Ltd.405 Wharfedale Road

Wokingham
Berkshire RG41 5RA

England United Kingdom
12/22/202121432