Singapore HSA registration DE0509894
Roche Diagnostics cobas® Online TDM Phenytoin
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered October 10, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509894
- Registration Date
- October 10, 2024
- Change Notification Approval Date
- April 11, 2025
- Retention Due Date
- October 09, 2025
Product description
In vitro test for the quantitative determination of total and free phenytoin in human serum and plasma on cobas c systems. The determination of total and free phenytoin is used in monitoring levels of total and free phenytoin to ensure appropriate therapy
Product Owner
- Short Name
- Roche Diagnostics GmbH
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
- Model Name(s)
- Preciset ® TDM I Online TDM Phenytoin TDM Control Set Online TDM Phenytoin Online TDM Phenytoin Online TDM Phenytoin
- Model Identifier(s)
- 3375790190 4490932190 4521536190 5108411190 8058601190 8445567190
About this record
Access comprehensive regulatory information for Roche Diagnostics cobas® Online TDM Phenytoin 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 DE0509894 and owned by Roche Diagnostics GmbH. The device was registered on October 10, 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 C IVD