Singapore HSA registration DE0510714
SENTINEL Easy-Card Occult Blood
Singapore·CLASS B IVD·SENTINEL CH. S.p.A.·Registered May 13, 2025Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD