Philippines FDA registration IVDR-00848

Elecsys HBsAg Confirmatory Test Kit

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Manheim, Germany·Germany·Issued April 22, 2025 – May 29, 2030
Device information
Product Name
Elecsys HBsAg Confirmatory Test Kit
Registration Number
IVDR-00848
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
April 22, 2025
Expiry Date
May 29, 2030
About this record

Access comprehensive regulatory information for Elecsys HBsAg Confirmatory Test Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00848 and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Manheim, Germany in Germany. The device was registered on April 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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