Singapore HSA registration DE0506659
Siemens Atellica IM Quantitative HBsAg (QHBs)
Singapore·CLASS C IVD·Siemens Healthcare Diagnostics Products Limited·Registered February 17, 2022Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD