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

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Page(s) 1
Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Helena Biosciences EuropeQueensway South Team Valley Trading Estate

Gateshead
Tyne And Wear NE11 0SD

United Kingdom





03/30/20157193
Quidel Cardiovascular Inc.9975 Summers Ridge Road

San Diego CA
92121

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
11/05/202119831
Siemens Healthcare Diagnostics Products GmbHEmil-Von-Behring-Str. 76

Marburg
35041

Germany
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
11/09/202119197
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
Zhejiang PushKang Biotechnology Co. Ltd.C408 Science and Technology Innovation Park No. 398 Mahuan Road Binhai New Area Shaoxing

Zhejiang Province
312366

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/17/202226967