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Singapore HSA registration DE0508070

bioMérieux VITEK® MS PRIME

Singapore flagSingapore·CLASS C IVD·BIOMERIEUX S.A.·Registered May 04, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0508070
Registration Date
May 04, 2023
Change Notification Approval Date
April 11, 2025
Retention Due Date
May 03, 2026
Product description
VITEK® MS PRIME 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 PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. The VITEK® MS PRIME system and this manual are intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.
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 CHCA VITEK® MS FA VITEK® MS MYCOBACTERIUM/NOCARDIA KIT VITEK® MS MOULD KIT VITEK® MS KB V3.2 CLNICAL VITEK MS PRIME VITEK® FLEXPREP Mainframe DVD VITEK MS SW V1.1 + KB 3.2 UDI VITEK MS KB 3.3
Model Identifier(s)
410893 411071 411072 415659 415680 422248 423281 423370 423882 424203
About this record

Access comprehensive regulatory information for bioMérieux VITEK® MS PRIME 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 DE0508070 and owned by BIOMERIEUX S.A.. The device was registered on May 04, 2023.

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