Singapore HSA registration DE0503000
Sentinel Diagnostics Alinity c Iron
Singapore·CLASS B IVD·Sentinel CH. SpA·Registered April 15, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503000
- Registration Date
- April 15, 2019
- Change Notification Approval Date
- August 17, 2023
- Retention Due Date
- April 14, 2026
Product description
The Alinity c Iron assay is used for the direct colorimetric determination of iron without deproteinization in human serum or plasma on the Alinity c analyzer.
Product Owner
- Name
- Sentinel CH. SpA
- Short Name
- Sentinel CH. SpA
- Address
- Via Robert Koch 2, 20152 MILANO, ITALY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Alinity c Iron Calibrator Kit Alinity c Iron Assay File Alinity c Iron Reagent Kit Alinity c Clinical Chemistry Control 1 Kit Alinity c Clinical Chemistry Control 2 Kit
- Model Identifier(s)
- 04U7501 08P39-1B 08P3920 08P6515 08P6516
About this record
Access comprehensive regulatory information for Sentinel Diagnostics Alinity c Iron 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 DE0503000 and owned by Sentinel CH. SpA. The device was registered on April 15, 2019.
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