Manufacturer's By Device Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)-Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA), Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA) Conformity Assessment Certificate Expired

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France
bioMérieux UK LtdGrafton House Grafton Way Unit H

Basingstoke
Hampshire RG22 - 6HY

England United Kingdom
03/30/202113038
DIALAB GmbHIZ NOE-Sued Hondastrasse
Objekt M55 IZ NOE-Sued
Wr. Neudorf
2351

Austria
Alpha Laboratories LtdUnit 40 Parham Drive

Eastleigh
Hampshire SO50 4NU

United Kingdom
11/12/202119029
Shenzhen YHLO Biotech Co. Ltd.Building 1 YHLO Biopark Baolong 2nd Road Baolong Subdistrict Longgang District

Shenzhen Guangdong
518116

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/30/202011290
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedSir William Siemens Square Frimley

Camberley
Surrey GU16 8QD

England United Kingdom
04/01/201532
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedSir William Siemens Square Frimley

Camberley
Surrey GU16 8QD

England United Kingdom
04/01/201532
Tosoh CorporationShiba-koen First Bldg. 3-8-2 Shiba Minato-ku

Tokyo
105-8623

Japan
Tosoh Bioscience Limited100 Longwater Avenue

Reading
Berkshire RG2 6GP

England United Kingdom
06/30/202115586