Singapore HSA registration DE0507646
Ortho-Clinical Resolve® Panel B
Singapore·CLASS D IVD·Ortho-Clinical Diagnostics·Registered January 03, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0507646
- Registration Date
- January 03, 2023
- Change Notification Approval Date
- November 06, 2024
- Retention Due Date
- January 02, 2026
Product description
Qualitative test to detect and/or identify unexpected blood group antibodies.
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)
- Resolve Panel B
- Model Identifier(s)
- 6901866
About this record
Access comprehensive regulatory information for Ortho-Clinical Resolve® Panel B 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 DE0507646 and owned by Ortho-Clinical Diagnostics. The device was registered on January 03, 2023.
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