Singapore HSA registration DE0510537
Diagast HEMA Cells A1, B, A2, O (PK1 & PK2)
Singapore·CLASS D IVD·Diagast·Registered April 02, 2025Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510537
- Registration Date
- April 02, 2025
- Retention Due Date
- April 01, 2026
Product description
These reagents are IVDMD intended to be used by healthcare professionals, biologists or lab technicians for the qualitative detection of anti-erythrocytic antibodies to test the ABO reverse blood grouping in donor blood samples with anticoagulant (EDTA) using a microplate automated method. The determination of the reverse (antibody) typing with the forward (antigen) typing in donors is intended to ensure immunological compatibility and safe transfusion of blood and blood components.
Product Owner
- Name
- Diagast
- Short Name
- Diagast
- Address
- 251 avenue Eugene Avinee, Eurasante Parc, 59120 LOOS FRANCE, FRANCE
Registrant
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
- Model Name(s)
- HEMA CELLS A1, B (PK1) HEMA CELLS A2 (PK1) HEMA CELLS O (PK1) CONTROL PK BROMELINE PK HEMA CELLS A1, B (PK2) HEMA CELLS A2 (PK2) HEMA CELLS O (PK2)
- Model Identifier(s)
- B10347 B10348 B10349 B10350 B10351 B10903 B10904 B10905
About this record
Access comprehensive regulatory information for Diagast HEMA Cells A1, B, A2, O (PK1 & PK2) 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 DE0510537 and owned by Diagast. The device was registered on April 02, 2025.
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