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Siemens Atellica IM Quantitative HBsAg (QHBs) - HSA Registration DE0506659

Access comprehensive regulatory information for Siemens Atellica IM Quantitative HBsAg (QHBs) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506659 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on February 17, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C IVD
DE0506659
Siemens Atellica IM Quantitative HBsAg (QHBs)
HSA Registration Number: DE0506659
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Product Description

The Atellica® IM Quantitative HBsAg (QHBs) assay is for in vitro diagnostic use in the quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma (dipotassium EDTA and lithium heparin) that are confirmed positive for HBsAg using the Atellica® Analyzer

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0506659
Registration Date
February 17, 2022
Change Notification Approval Date
April 24, 2025
Retention Due Date
February 16, 2026
Product Owner
Short Name
Siemens Healthcare Diagnostics Products Limited
Address
Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, UNITED KINGDOM
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Atellica IM PW3 Atellica IM QHBs Atellica IM QHBs QC Atellica IM QHBs MCM Atellica IM Multi‑Diluent 14
Model Identifier(s)
10995666 11200643 11200644 11200651 11200662