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Sentinel Diagnostics Total Bile Acids Liquid - HSA Registration DE0510563

Access comprehensive regulatory information for Sentinel Diagnostics Total Bile Acids Liquid 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 DE0510563 and owned by Sentinel CH. SpA. The device was registered on April 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.

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CLASS B IVD
DE0510563
Sentinel Diagnostics Total Bile Acids Liquid
HSA Registration Number: DE0510563
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Product Description

The Total Bile Acids Liquid assay is intended for the enzymatic cycling colorimetric determination of total bile acids in serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510563
Registration Date
April 07, 2025
Retention Due Date
April 06, 2026
Product Owner
Short Name
Sentinel CH. SpA
Address
Via Robert Koch 2, 20152 MILANO, ITALY
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)
Total Bile Acids Control Set Total Bile Acids Liquid
Model Identifier(s)
1600201 1700201