Philippines FDA registration IVDR-00437A

ELECSYS ANTI-Hbe (REAGENT KIT)

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Mannheim, Germany·Germany·Issued December 28, 2020 – November 15, 2025
Device information
Product Name
ELECSYS ANTI-Hbe (REAGENT KIT)
Registration Number
IVDR-00437A
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines), Inc.
Registration dates
Issuance Date
December 28, 2020
Expiry Date
November 15, 2025
About this record

Access comprehensive regulatory information for ELECSYS ANTI-Hbe (REAGENT KIT) in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00437A and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Mannheim, Germany in Germany. The device was registered on December 28, 2020.

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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