Singapore HSA registration DE0017288
Bio-Rad VRESelect
Singapore·CLASS C IVD·Bio-Rad France·Registered July 01, 2015Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0017288
- Registration Date
- July 01, 2015
- Change Notification Approval Date
- January 25, 2024
- Retention Due Date
- June 30, 2025
Product description
VRESelect is a selective and differential chromogenic medium for the qualitative detection and identification of vancomycinresistant Enterococcus faecium (VRE-fm) and vancomycin-resistant Enterococcus faecalis (VRE-fs). The test is performed on rectal swabs or fecal specimens to screen patients or healthcare workers for VRE gastrointestinal colonization.
Product Owner
- Name
- Bio-Rad France
- Short Name
- Bio-Rad France
- Address
- 3, boulevard Raymond Poincare, 92430 Marnes-la-Coquette, FRANCE
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- VRESelect VRESelect
- Model Identifier(s)
- 63751 63752
About this record
Access comprehensive regulatory information for Bio-Rad VRESelect 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 DE0017288 and owned by Bio-Rad France. The device was registered on July 01, 2015.
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