Philippines FDA registration IVDR-00408B

PreciControl Anti-HBc II

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany·Germany·Issued May 22, 2025 – July 12, 2031
Device information
Product Name
PreciControl Anti-HBc II
Registration Number
IVDR-00408B
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
May 22, 2025
Expiry Date
July 12, 2031
About this record

Access comprehensive regulatory information for PreciControl Anti-HBc II in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00408B and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany in Germany. The device was registered on May 22, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines) Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.

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