Singapore HSA registration DE0506428
Sentinel Diagnostics Ceruloplasmin
Singapore·CLASS B IVD·Sentinel CH. SpA·Registered November 30, 2021Device 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 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 Atellica® CH Analyzer.
Product Owner
- Name
- Sentinel CH. SpA
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD