Singapore HSA registration DE0510693
Siemens Atellica IM DHEAS2
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered May 07, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510693
- Registration Date
- May 07, 2025
- Retention Due Date
- May 06, 2026
Product description
The Atellica® IM DHEAS2 assay is for in vitro diagnostic use in the quantitative determination of DHEAS in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzer. Measurements of DHEAS are used in the evaluation of adrenal gland function and as an aid in the diagnosis of disorders associated with the adrenal glands.
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
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- Atellica IM Multi‑Diluent 3 Atellica IM DHEAS2 Atellica IM DHEAS2 MCM
- Model Identifier(s)
- 10995645 11209193 11209195
About this record
Access comprehensive regulatory information for Siemens Atellica IM DHEAS2 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 DE0510693 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on May 07, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD