Singapore HSA registration DE0509774
Geenius Reader
Singapore·CLASS D IVD·Bio-Rad·Registered September 11, 2024Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509774
- Registration Date
- September 11, 2024
- Retention Due Date
- September 10, 2025
Product description
The Geenius™ Reader is intended for the reading of cassettes included in Bio-Rad test kits. Reactive bands on a cassette are detected by the onboard camera. The associated Geenius™ Software then performs the detection data analysis and the result evaluation according to predefined rules.
Product Owner
- Name
- Bio-Rad
- Short Name
- Bio-Rad
- 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)
- Geenius Software Geenius Reader
- Model Identifier(s)
- 92461 92465
About this record
Access comprehensive regulatory information for Geenius Reader in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0509774 and owned by Bio-Rad. The device was registered on September 11, 2024.
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 D IVD