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SENTINEL Easy-Card Occult Blood - HSA Registration DE0510714

Access comprehensive regulatory information for SENTINEL Easy-Card Occult Blood 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 DE0510714 and owned by SENTINEL CH. S.p.A.. The device was registered on May 13, 2025.

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
DE0510714
SENTINEL Easy-Card Occult Blood
HSA Registration Number: DE0510714
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Product Description

The Easy-Card Occult Blood test has been developed for the qualitative determination of human hemoglobin (Hb) in feces (fecal occult blood - FOB) and can be used for screening many lower gastrointestinal tract conditions associated with bleeding such as carcinoma, colorectal 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.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510714
Registration Date
May 13, 2025
Retention Due Date
May 12, 2026
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)
Easy-Card Occult Blood
Model Identifier(s)
14800