Philippines FDA registration IVDR-00343B

Alinity i Anti-HBc II Calibrator

Philippines flagPhilippines·Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany·Germany·Issued June 11, 2025 – November 09, 2029
Device information
Product Name
Alinity i Anti-HBc II Calibrator
Registration Number
IVDR-00343B
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Abbott Laboratories
Registration dates
Issuance Date
June 11, 2025
Expiry Date
November 09, 2029
About this record

Access comprehensive regulatory information for Alinity i Anti-HBc II Calibrator in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00343B and manufactured by Abott GmbH - Max-Planck-Ring 2, 65205 Wiesbaden, Germany in Germany. The device was registered on June 11, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Abbott Laboratories), 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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