Singapore HSA registration DE0506382
Siemens Atellica IM Anti-Thyroglobulin II (aTgII)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Products Limited·Registered November 16, 2021Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506382
- Registration Date
- November 16, 2021
- Change Notification Approval Date
- March 05, 2025
- Retention Due Date
- November 15, 2025
Product description
The Atellica® IM Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) using the Atellica® Analyzer. Anti-thyroglobulin (aTg, TgAb) measurements are used as an aid in the diagnosis of Hashimoto’s and Graves’ diseases, which are autoimmune diseases affecting the thyroid gland.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Products Limited
- Address
- Gly 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 aTgII MCM Atellica IM aTgII QC Atellica IM aTgII Atellica IM aTgII
- Model Identifier(s)
- 11201751 11201752 11201759 11201761
About this record
Access comprehensive regulatory information for Siemens Atellica IM Anti-Thyroglobulin II (aTgII) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506382 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on November 16, 2021.
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 B IVD