HSA · registration DE0510714SENTINEL Easy-Card Occult Blood
- Registration number
- DE0510714
- Model name
- Easy-Card Occult Blood
- Model identifier
- 14800
- Registration date
- May 13, 2025
- Risk class
- Class B
- Product owner
- SENTINEL CH. S.p.A.
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
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 address
- Via Robert Koch, 2, Milano (MI), 20152, Italy
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.