Singapore HSA registration DE0502312
bioMérieux VIDAS® CMV IgM
Singapore·CLASS C IVD·BIOMERIEUX S.A.·Registered November 01, 2018Device 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 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).
Product Owner
- Name
- BIOMERIEUX S.A.
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD