Singapore HSA registration DE0510453
Siemens Atellica CH Urine Albumin (UAlb)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered March 12, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510453
- Registration Date
- March 12, 2025
- Retention Due Date
- March 11, 2026
Product description
The Atellica® CH Urine Albumin (UAlb) assay is for in vitro diagnostic use in the quantitative determination of albumin in human urine using the Atellica Analyzers. Measurement of albumin aids in the diagnosis of kidney diseases.
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 CH Urine Albumin (UAlb) Atellica CH Urine Albumin Calibrator (UAlb CAL)
- Model Identifier(s)
- 11537225 11537247
About this record
Access comprehensive regulatory information for Siemens Atellica CH Urine Albumin (UAlb) 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 DE0510453 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on March 12, 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