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Siemens Atellica IM Anti-Thyroglobulin II (aTgII) - HSA Registration DE0506382

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.

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CLASS B IVD
DE0506382
Siemens Atellica IM Anti-Thyroglobulin II (aTgII)
HSA Registration Number: DE0506382
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Product Description

The Atellicaยฎ 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 Atellicaยฎ Analyzer. Anti-thyroglobulin (aTg, TgAb) measurements are used as an aid in the diagnosis of Hashimotoโ€™s and Gravesโ€™ diseases, which are autoimmune diseases affecting the thyroid gland.

Device 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 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