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bioMérieux VIDAS® CMV IgM - HSA Registration DE0502312

Access comprehensive regulatory information for bioMérieux VIDAS® CMV IgM in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0502312 and owned by BIOMERIEUX S.A.. The device was registered on November 01, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C IVD
DE0502312
bioMérieux VIDAS® CMV IgM
HSA Registration Number: DE0502312
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Product Description

VIDAS CMV IgM is an automated qualitative enzyme immunoassay for use on the VIDAS family instruments, for the detection of anti-cytomegalovirus IgM (CMVM) in human serum, using the ELFA technique (Enzyme Linked Fluorescent Assay).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0502312
Registration Date
November 01, 2018
Change Notification Approval Date
December 08, 2022
Retention Due Date
October 31, 2025
Product Owner
Short Name
BIOMERIEUX
Address
Chemin de l'Orme,, 69280 MARCY L ETOILE FRANCE, FRANCE
Registrant
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model Information
Model Name(s)
VIDAS® CMV IgM (60 tests per box)
Model Identifier(s)
30205