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Singapore HSA registration DE0502274

bioMérieux VIDAS® High Sensitive Troponin I (TNHS)

Singapore flagSingapore·CLASS C IVD·BIOMERIEUX S.A.·Registered October 18, 2018
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0502274
Registration Date
October 18, 2018
Change Notification Approval Date
August 08, 2023
Retention Due Date
October 17, 2025
Product description
VIDAS® High sensitive Troponin I is an automated quantitative test for use on the instruments of the VIDAS® family for the determination of human cardiac troponin I in human serum or plasma, using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® High sensitive Troponin I assay is intended to be used as an aid in the diagnosis of myocardial infarction (MI) and for the risk stratification of patients with symptoms suggestive of acute coronary syndrome (ACS) with respect to relative risk of all-cause mortality and major adverse cardiac events (MACE) consisting of myocardial infarction and revascularization, at 30 days. This assay is intended for use in clinical laboratories (centralized or decentralized) by qualified laboratory professionals.
Product Owner
Name
BIOMERIEUX S.A.
Short Name
BIOMERIEUX
Address
Chemin de l'Orme,, 69280 MARCY L ETOILE FRANCE, FRANCE
Registrant
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Name
BIOMERIEUX SINGAPORE PTE. LTD. Biomerieux Asia Pacific Pte. Ltd.
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
Model Name(s)
VIDAS® High Sensitive Troponin I (TNHS), 60 tests
Model Identifier(s)
415386
About this record

Access comprehensive regulatory information for bioMérieux VIDAS® High Sensitive Troponin I (TNHS) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0502274 and owned by BIOMERIEUX S.A.. The device was registered on October 18, 2018.

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 C IVD