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SENTINEL SENTiFOB® - HSA Registration DE0509304

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.

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CLASS B IVD
DE0509304
SENTINEL SENTiFOB®
HSA Registration Number: DE0509304
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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.

Device 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 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