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Siemens CLINITEK Advantus Semi-Automated Urinalysis Analyzer - HSA Registration DE0510418

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.

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CLASS B IVD
DE0510418
Siemens CLINITEK Advantus Semi-Automated Urinalysis Analyzer
HSA Registration Number: DE0510418
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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: โ€ข Kidney disease โ€ข Urinary tract infections โ€ข Metabolic disorders, such as diabetes mellitus โ€ข Liver disease The analyzer is for professional use in centralized laboratory settings.

Device 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 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)