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Sentinel Diagnostics Ceruloplasmin - HSA Registration DE0506428

Access comprehensive regulatory information for Sentinel Diagnostics Ceruloplasmin 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 DE0506428 and owned by Sentinel CH. SpA. The device was registered on November 30, 2021.

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
DE0506428
Sentinel Diagnostics Ceruloplasmin
HSA Registration Number: DE0506428
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Product Description

The Ceruloplasmin assay is to be used for the quantitative immunoturbidimetric determination of ceruloplasmin in serum and plasma. The Ceruloplasmin assay is to be used with Atellicaยฎ CH Analyzer.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0506428
Registration Date
November 30, 2021
Retention Due Date
November 29, 2025
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)
Ceruloplasmin Plasmaproteins Cal 3x Immuno Control Set (2 levels)
Model Identifier(s)
11065N 11206D 11211A