Philippines FDA registration IVDR-00646A

ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII) ASSAY

Philippines·Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, USA·USA·Issued November 18, 2021 – November 18, 2022

Device information

Product Name: ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII) ASSAY
Registration Number: IVDR-00646A

Manufacturer details

Manufacturer: Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, USA
Country of Origin: USA

Importer & distribution

Importer/Distributor: Siemens Healthcare Inc.

Registration dates

Issuance Date: November 18, 2021
Expiry Date: November 18, 2022

About this record

Access comprehensive regulatory information for ATELLICA™ IM HEPATITIS B SURFACE ANTIGEN II (HBsII) ASSAY in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00646A and manufactured by Siemens Healthcare GmbH - Munich, Germany mfd. By: Siemens Healthcare Diagnostics Inc.- MA, USA For: Siemens Healthcare Diagnostics Inc. - Tarrytown, USA in USA. The device was registered on November 18, 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.