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Siemens Atellica IM TSH3-Ultra II (TSH3ULII) - HSA Registration DE0510278

Access comprehensive regulatory information for Siemens Atellica IM TSH3-Ultra II (TSH3ULII) 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 DE0510278 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on January 23, 2025.

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
DE0510278
Siemens Atellica IM TSH3-Ultra II (TSH3ULII)
HSA Registration Number: DE0510278
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Product Description

The Atellica® IM TSH3‑Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0510278
Registration Date
January 23, 2025
Retention Due Date
January 22, 2026
Product Owner
Short Name
Siemens Healthcare, USA
Address
511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
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 15 Atellica IM TSH3-Ultra II (TSH3ULII) Atellica IM TSH3-Ultra II (TSH3ULII) Atellica IM TSH3ULII Master Curve Material (TSH3ULII MCM)
Model Identifier(s)
11200798 11208706  11208707  11208876