Singapore HSA registration DE0509304
SENTINEL SENTiFOB®
Singapore·CLASS B IVD·SENTINEL CH. S.p.A.·Registered May 20, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509304
- Registration Date
- May 20, 2024
- Retention Due Date
- May 19, 2025
Product description
The SENTiFOB® is an automated analyzer intended for the determination of analytes in human specimen. The SENTiFOB® analyzer is an automatic random access analyzer specially designed for performing Fecal Immunochemical Test (FIT) analyses. For laboratory professional use only.
Product Owner
- Short Name
- SENTINEL CH. S.p.A.
- Address
- Via Robert Koch, 2, Milano (MI), 20152, ITALY
Registrant
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
- Address
- 18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
- Model Name(s)
- SENTiFOB Reaction Rotor Concentrated Washing Solution Concentrated System Liquid
- Model Identifier(s)
- 580001 SD8000 SD8001 SD8002
About this record
Access comprehensive regulatory information for SENTINEL SENTiFOB® 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 DE0509304 and owned by SENTINEL CH. S.p.A.. The device was registered on May 20, 2024.
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