Manufacturer's By Device 2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)-2-ethylidine-15-dimethyl-33-diphenylpyrrolidine (EDDP) IVD kit enzyme immunoassay (EIA)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
ARK Diagnostics Inc.48089 Fremont Blvd

Fremont
California 94538

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

Cambridge
CB24 9BZ

England United Kingdom
11/08/202119952
Beckman Coulter Ireland Inc.Lismeehan

O'Callaghan's Mills
Co. Clare N/A

Ireland
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/19/202220063
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
Immunalysis Corporation829 Towne Center Drive

Pomona
California 91767

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

England United Kingdom
11/01/202119091
Lin-Zhi International Inc.2945 Oakmead Village Court

Santa Clara
California 95051

United States
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
10/15/202118294
Matrix Diagnostics LtdMatrix Diagnostics Ltd Unit 9 Merdian Business Park Fleming Road Waltham Abbey
Waltham Abbey
Waltham Abbey
Essex EN9 3BZ

United Kingdom





12/04/20199393
Microgenics Corporation46500 Kato Road

Fremont
California CA 94538

United States
Thermo Fisher Diagnostics Ltd.16 Shenley Pavillions Chalkdell Drive
Shenley Wood
Milton Keynes
MK5 6LB

England United Kingdom
07/14/202225266
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