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Singapore HSA registration DE0510629

SENTINEL CALiaGold®

Singapore flagSingapore·CLASS B IVD·SENTINEL CH. S.p.A.·Registered April 24, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0510629
Registration Date
April 24, 2025
Retention Due Date
April 23, 2026
Product 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.
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)
CALiaGold® CALiaGold® RV CALiaGold® Control Set CALiaGold® pierceTube CALiaGold® Sample diluent CALiaGold® Tube CALiaGold® Calibrator Set
Model Identifier(s)
1151000 1151001 1151200 1151300 1151400 1151500 1151600
About this record

Access comprehensive regulatory information for SENTINEL CALiaGold® 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 DE0510629 and owned by SENTINEL CH. S.p.A.. The device was registered on April 24, 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