Philippines FDA registration IVDR-00883

Elecsys Syphilis Test Kit

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305, Mannheim, Germany·Germany·Issued March 12, 2025 – March 12, 2026
Device information
Product Name
Elecsys Syphilis Test Kit
Registration Number
IVDR-00883
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines), Inc.
Registration dates
Issuance Date
March 12, 2025
Expiry Date
March 12, 2026
About this record

Access comprehensive regulatory information for Elecsys Syphilis Test Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00883 and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305, Mannheim, Germany in Germany. The device was registered on March 12, 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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