United Kingdom MHRA device registration 79511

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·EUROIMMUN Medizinische Labordiagnostika AG·Registered Nov 26, 2024

Registration details

Device ID: 79511
MHRA Reference Number: 79511
Date Registered: Nov 26, 2024
Last Updated: Aug 31, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD Annex II List B

Manufacturer

Name: EUROIMMUN Medizinische Labordiagnostika AG
Address: Seekamp 31
Lubeck, Germany
Created Date: May 5, 2021

Authorized Representative

Name: Euroimmun UK Limited
Relationship Type: UK Responsible Person
Address: Ashville House 131-139 The Broadway
Wimbledon, London, England, United Kingdom
Postcode: SW19 1QJ

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About this record

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 79511. The device is manufactured by EUROIMMUN Medizinische Labordiagnostika AG from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Euroimmun UK Limited.

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