Singapore HSA registration DE0508308
Siemens Atellica IM Thyroglobulin (Tg)
Singapore·CLASS C IVD·Siemens Healthcare Diagnostics Products Limited·Registered July 18, 2023Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0508308
- Registration Date
- July 18, 2023
- Change Notification Approval Date
- July 29, 2024
- Retention Due Date
- July 17, 2025
Product description
The Atellica® IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
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 Multi‑Diluent 11 Atellica IM Multi‑Diluent 11 Atellica IM Tg MCM Atellica IM Thyroglobulin (Tg) Atellica IM Thyroglobulin (Tg)
- Model Identifier(s)
- 10995641 10995642 11200449 11200450 11200534
About this record
Access comprehensive regulatory information for Siemens Atellica IM Thyroglobulin (Tg) 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 DE0508308 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on July 18, 2023.
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