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Siemens Atellica IM Thyroglobulin (Tg) - HSA Registration DE0508308

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.

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CLASS C IVD
DE0508308
Siemens Atellica IM Thyroglobulin (Tg)
HSA Registration Number: DE0508308
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Product Description

The Atellicaยฎ 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 Atellicaยฎ Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

Device 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 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 Multiโ€‘Diluent 11 Atellica IM Multiโ€‘Diluent 11 Atellica IM Tg MCM Atellica IM Thyroglobulin (Tg) Atellica IM Thyroglobulin (Tg)
Model Identifier(s)
10995641 10995642 11200449 11200450 11200534