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Singapore HSA registration DE0505528

bioMerieux VITEK® MS

Singapore flagSingapore·CLASS C IVD·BIOMERIEUX S.A.·Registered March 05, 2021
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0505528
Registration Date
March 05, 2021
Change Notification Approval Date
February 15, 2024
Retention Due Date
March 04, 2026
Product description
VITEK® MS is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS system is a qualitative in vitro diagnostic device used in conjunction with other laboratory tests to aid in the diagnosis of bacterial, yeast and mould infections.
Product Owner
Name
BIOMERIEUX S.A.
Short Name
BIOMERIEUX S.A.
Address
376,, Chemin de l’Orme 69280, Marcy L Etoile, FRANCE
Registrant
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
Model Name(s)
VITEK® MS -DS VITEK® MS INSTRUMENT VITEK® MS CHCA VITEK® MS FA VITEK® MS RP5810 DVD V3.0 VITEK® MS V3.0 CLINICAL UPDATE KIT (CD) VITEK® MS RP5800 MASTERS V3.0 CLINICAL KIT VITEK® MS CD KB V3.2 CLINICAL VITEK® MS SW v1.0 and FlexPrep v1.0 CL DVD VITEK® FLEXPREP Mainframe DVD
Model Identifier(s)
410893 410895 411071 411072 412598 420950 420986 422248 423234 423370
About this record

Access comprehensive regulatory information for bioMerieux VITEK® MS 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 DE0505528 and owned by BIOMERIEUX S.A.. The device was registered on March 05, 2021.

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