Singapore HSA registration DE0510089
Ortho-Clinical Affirmagen
Singapore·CLASS D IVD·Ortho-Clinical Diagnostics·Registered November 28, 2024Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510089
- Registration Date
- November 28, 2024
- Retention Due Date
- November 27, 2025
Product description
For in vitro diagnostic use. To confirm the ABO forward (red cell) group.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics
- Address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- Affirmagen Affirmagen 4
- Model Identifier(s)
- 6901861 719220
About this record
Access comprehensive regulatory information for Ortho-Clinical Affirmagen 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 DE0510089 and owned by Ortho-Clinical Diagnostics. The device was registered on November 28, 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