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BioMerieux VIDAS®TOXO IgM - HSA Registration DE0502938

Access comprehensive regulatory information for BioMerieux VIDAS®TOXO 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 DE0502938 and owned by BIOMERIEUX S.A.. The device was registered on March 28, 2019.

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
DE0502938
BioMerieux VIDAS®TOXO IgM
HSA Registration Number: DE0502938
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Product Description

VIDAS TOXO IgM is an automated qualitative test for use on the VIDAS family instruments, for the detection of antitoxoplasma IgM in serum using the ELFA technique (Enzyme Linked Fluorescent Assay).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0502938
Registration Date
March 28, 2019
Change Notification Approval Date
August 13, 2024
Retention Due Date
March 27, 2026
Product Owner
Short Name
BIOMERIEUX S.A.
Address
376,, Chemin de l’Orme 69280, Marcy L Etoile, 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® TOXO IgM
Model Identifier(s)
30202