Singapore HSA registration DE0502938
BioMerieux VIDAS®TOXO IgM
Singapore·CLASS C IVD·BIOMERIEUX S.A.·Registered March 28, 2019Device 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 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).
Product Owner
- Name
- BIOMERIEUX S.A.
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD