Pure Global

Sentinel Diagnostics Alinity c Iron - HSA Registration DE0503000

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0503000
Sentinel Diagnostics Alinity c Iron
HSA Registration Number: DE0503000
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 Owner
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