Singapore HSA registration DE0012636
Bio-Rad OptiMAL-IT
Singapore·CLASS C IVD·Bio-Rad·Registered March 25, 2013Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0012636
- Registration Date
- March 25, 2013
- Change Notification Approval Date
- October 18, 2018
- Retention Due Date
- March 24, 2026
Product description
OptiMAL-IT is a rapid malaria test, is intended for diagnosis and therapy control of an infection by Plasmodium species (Malaria).
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)
- OptiMal Positive Control OptiMal-IT
- Model Identifier(s)
- 710011 710024
About this record
Access comprehensive regulatory information for Bio-Rad OptiMAL-IT 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 DE0012636 and owned by Bio-Rad. The device was registered on March 25, 2013.
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