Singapore HSA registration DE0502371
bioMérieux RAPIDEC® CARBA NP
Singapore·CLASS C IVD·BIOMERIEUX S.A.·Registered November 23, 2018Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0502371
- Registration Date
- November 23, 2018
- Change Notification Approval Date
- August 08, 2023
- Retention Due Date
- November 22, 2025
Product description
Rapid test for the detection of carbapenemase-producing Gram-negative bacilli.
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)
- RAPIDEC® CARBA NP RAPIDEC® CARBA NP
- Model Identifier(s)
- 415418 417498
About this record
Access comprehensive regulatory information for bioMérieux RAPIDEC® CARBA NP 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 DE0502371 and owned by BIOMERIEUX S.A.. The device was registered on November 23, 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