Singapore HSA registration DE0502760
bioMérieux VIDAS® CK-MB
Singapore·CLASS C IVD·BIOMERIEUX S.A.·Registered February 07, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0502760
- Registration Date
- February 07, 2019
- Retention Due Date
- February 06, 2026
Product description
VIDAS CK-MB is an automated quantitative test for use on the VIDAS family instruments for the quantitative measurement of the MB isoenzyme of human creatine kinase in human serum or plasma (lithium heparin or EDTA), 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® CK-MB, 30 tests
- Model Identifier(s)
- 30421
About this record
Access comprehensive regulatory information for bioMérieux VIDAS® CK-MB 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 DE0502760 and owned by BIOMERIEUX S.A.. The device was registered on February 07, 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