United Kingdom MHRA device registration 177685

Cancer antigen 15-3 (CA15-3) IVD, calibrator

United Kingdom·In Vitro Diagnostic Device·BRAHMS GmbH·Registered Nov 26, 2024

Registration details

Device ID: 177685
MHRA Reference Number: 177685
Date Registered: Nov 26, 2024
Last Updated: Oct 3, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cancer antigen 15-3 (CA15-3) IVD, calibrator
Type: Class C

Manufacturer

Name: BRAHMS GmbH
Address: Neuendorfstr. 25
Hennigsdorf, Germany
Created Date: Jul 11, 2022

Authorized Representative

Name: Thermo Fisher Diagnostics Ltd.
Relationship Type: UK Responsible Person
Address: Stafford House Boundary Way
Hemel Hempstead, England, United Kingdom
Postcode: HP27GE

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About this record

Cancer antigen 15-3 (CA15-3) IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 177685. The device is manufactured by BRAHMS GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Thermo Fisher Diagnostics Ltd..

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