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Roche Diagnostics cobas® Online TDM Phenytoin - HSA Registration DE0509894

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.

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CLASS C IVD
DE0509894
Roche Diagnostics cobas® Online TDM Phenytoin
HSA Registration Number: DE0509894
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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

Device 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 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