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Singapore HSA registration DE0509727

SENTINEL FOB Gold® NG Wide

Singapore flagSingapore·CLASS B IVD·SENTINEL CH. S.p.A.·Registered September 04, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0509727
Registration Date
September 04, 2024
Retention Due Date
September 03, 2025
Product description
The FOB Gold® NG Wide test allows the quantitative determination of human hemoglobin (Hb) in feces and, being easily applicable on clinical chemistry automated analyzers, it can be used for screening many lower gastrointestinal tract conditions associated with bleeding such as colorectal carcinoma, colon polyps, Crohn’s disease and ulcerative colities. The method is specific for human hemoglobin and no restricted diet (meat-free or peroxidase-free diet) is required.
Product Owner
Name
SENTINEL CH. S.p.A.
Short Name
SENTINEL CH. S.p.A.
Address
Via Robert Koch, 2, Milano (MI), 20152, ITALY
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
FOB Gold® NG Wide SENTiFIT® pierceTube FOB Gold Tube Screen FOB Gold® Control Set Wide FOB Gold® Calibrator Wide FOB Gold® Screen Diluent
Model Identifier(s)
1156009 1156188 11561H 1157103 1157401 1157501
About this record

Access comprehensive regulatory information for SENTINEL FOB Gold® NG Wide 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 DE0509727 and owned by SENTINEL CH. S.p.A.. The device was registered on September 04, 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