Philippines FDA registration IVDR-00475A

ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (aHBs2) ASSAY

Philippines flagPhilippines·Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, United States·USA·Issued September 16, 2021 – February 14, 2026
Device information
Product Name
ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (aHBs2) ASSAY
Registration Number
IVDR-00475A
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Siemens Healthcare Inc.
Registration dates
Issuance Date
September 16, 2021
Expiry Date
February 14, 2026
About this record

Access comprehensive regulatory information for ATELLICA™ IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (aHBs2) ASSAY in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00475A and manufactured by Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc. - MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, NY, United States in USA. The device was registered on September 16, 2021.

This page provides complete registration details including manufacturer information, importer/distributor details (Siemens Healthcare 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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