Pure Global

Siemens Atelllica IM Anti-Thyroid Peroxidase II (aTPOII) - HSA Registration DE0510185

Access comprehensive regulatory information for Siemens Atelllica IM Anti-Thyroid Peroxidase II (aTPOII) 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 DE0510185 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on December 30, 2024.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0510185
Siemens Atelllica IM Anti-Thyroid Peroxidase II (aTPOII)
HSA Registration Number: DE0510185
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Atellicaยฎย IM Anti-Thyroid Peroxidase II (aTPOII) assay is for inย vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the Atellicaยฎ Analyzers. Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0510185
Registration Date
December 30, 2024
Retention Due Date
December 29, 2025
Product Owner
Short Name
Siemens Healthcare
Address
511 Benedict Avenue, Tarrytown, NY 10591-5097, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Atellica IM aTPOII Master Curve Material (aTPOII MCM) Atellica IM Anti-Thyroid Peroxidase II (aTPOII) Atellica IM Anti-Thyroid Peroxidase II (aTPOII) Atellica IM aTPOII Quality Control (aTPOII QC) Atellica IM aTPOII Diluent (aTPOII DIL)
Model Identifier(s)
11203694 11206076 11206077 11206984 11207637