United Kingdom MHRA device registration 88458

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

United Kingdom·In Vitro Diagnostic Device·Virion\Serion GmbH·Registered Jul 12, 2021

Registration details

Device ID: 88458
MHRA Reference Number: 88458
Date Registered: Jul 12, 2021
Last Updated: Oct 13, 2022

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: Virion\Serion GmbH
Address: Friedrich-Bergius-Ring 19
Wurzburg, Germany
Created Date: Jul 12, 2021

Authorized Representative

Name: Launch Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Ash House Ash Road New Ash Green
Longfield, Kent, United Kingdom
Postcode: DA3 8JD

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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 88458. The device is manufactured by Virion\Serion GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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