Singapore HSA registration DE0018672
Bio-Rad RPR
Singapore·CLASS C IVD·Bio-Rad·Registered October 18, 2016Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0018672
- Registration Date
- October 18, 2016
- Change Notification Approval Date
- February 19, 2025
- Retention Due Date
- October 17, 2025
Product description
RPR kits are intended for use for the qualitative and semiquantitative detection of non treponemal syphilis-associated antibodies (reagin) in human serum and plasma as an aid in the diagnosis in syphilis infection.
Product Owner
- Name
- Bio-Rad
- Short Name
- Bio-Rad
- Address
- 3, bvd 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)
- RPR RPR
- Model Identifier(s)
- 72515 72516
About this record
Access comprehensive regulatory information for Bio-Rad RPR 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 DE0018672 and owned by Bio-Rad. The device was registered on October 18, 2016.
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