Singapore HSA registration DE0510418
Siemens CLINITEK Advantus Semi-Automated Urinalysis Analyzer
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered March 04, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510418
- Registration Date
- March 04, 2025
- Retention Due Date
- March 03, 2026
Product description
This analyzer is intended for the semi-quantitative and qualitative type of measurement of the following in human urine samples: Albumin, Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein- to-Creatinine ratio, Albumin-to-Creatinine ratio, specific gravity, and Urobilinogen. These measurements are used to aid in assessment of conditions such as: • Kidney disease • Urinary tract infections • Metabolic disorders, such as diabetes mellitus • Liver disease The analyzer is for professional use in centralized laboratory settings.
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
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- CLINITEK Advantus Analyzer
- Model Identifier(s)
- 1420 (10484765)
About this record
Access comprehensive regulatory information for Siemens CLINITEK Advantus Semi-Automated Urinalysis Analyzer 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 DE0510418 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on March 04, 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