Philippines FDA registration IVDR-00421B

ELECSYS HCG+ß CALSET

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Mannheim, Germany·Germany·Issued March 08, 2021 – September 02, 2025
Device information
Product Name
ELECSYS HCG+ß CALSET
Registration Number
IVDR-00421B
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
March 08, 2021
Expiry Date
September 02, 2025
About this record

Access comprehensive regulatory information for ELECSYS HCG+ß CALSET in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00421B and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116, 68305 Mannheim, Germany in Germany. The device was registered on March 08, 2021.

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.

Free DatabasePowered by Pure Global AIFDA Official DataGermany