Singapore HSA registration DE0510185
Siemens Atelllica IM Anti-Thyroid Peroxidase II (aTPOII)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered December 30, 2024Device 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 description
The Atellica® IM Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzers. Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis.
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
About this record
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 DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD