United Kingdom MHRA device registration 121555

Coagulation analyser IVD, laboratory

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Tem Innovations GmbH·Registered Nov 26, 2024
Registration details
Device ID
121555
MHRA Reference Number
121555
Date Registered
Nov 26, 2024
Last Updated
Oct 8, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Coagulation analyser IVD, laboratory
Type
IVD General
Manufacturer
Address
Martin-Kollar- Strasse 15 81829
Munich, Germany
Created Date
Dec 15, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE
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About this record

Coagulation analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 121555. The device is manufactured by Tem Innovations GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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