Manufacturer's By Device D-dimer IVD calibrator-D-dimer IVD calibrator

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

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

United Kingdom
04/19/202214139
BIOKIT S.A.Av. Can Montcau 7 08186 Lliçà d'Amunt Barcelona

Barcelona
08186

Spain
Werfen Ltd712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE
Manchester
Manchester
WA3 6DE

England United Kingdom
04/13/202217511
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
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
Helena Biosciences EuropeQueensway South Team Valley Trading Estate

Gateshead
Tyne And Wear NE11 0SD

United Kingdom





03/30/20157193
Radiometer Medical ApSAakandevej 21 Broenshoej

Copenhagen
2700

Denmark
Radiometer LimitedManor Court/Manor Royal

Crawley
RH10 9FY

England United Kingdom
01/06/202221058
Thermo Fisher Scientific OyRatastie 2

Vantaa
Uusimaa 01620

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

England United Kingdom
07/12/202225260
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