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HSA · registration DE0510629

SENTINEL CALiaGold®

SingaporeGastroenterology & UrologyClass BSENTINEL CH. S.p.A.
Verified
Official record identity
Registration number
DE0510629
Model name
CALiaGold®; CALiaGold® RV; CALiaGold® Control Set; CALiaGold® pierceTube; CALiaGold® Sample diluent; CALiaGold® Tube; CALiaGold® Calibrator Set
Model identifier
1151000; 1151001; 1151200; 1151300; 1151400; 1151500; 1151600
Registration date
April 24, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
SENTINEL CH. S.p.A.
Registrant / registration holder
BIOMED DIAGNOSTICS PTE LTD
Official description

The CALiaGold® assay and CALiaGold® RV assay are in vitro diagnostic tests used for the determination of the calprotectin in human feces. The assays are intended for professional use only. For In Vitro Diagnostic use.

Additional source fields
Product owner address
Via Robert Koch, 2, Milano (MI), 20152, Italy
Registrant address
18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record

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.