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Singapore HSA registration DE0503158

bioMerieux VITEK 2 Instrument

Singapore flagSingapore·CLASS C IVD·bioMérieux Inc·Registered May 29, 2019
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0503158
Registration Date
May 29, 2019
Change Notification Approval Date
December 17, 2024
Retention Due Date
May 28, 2025
Product description
The VITEK® 2 System is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and yeast. The VITEK® 2 System is also intended for the automated identification of most clinically significant anaerobic organisms and Corynebacterium species, fermenting and non- fermenting Gram-negative bacilli, Gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.
Product Owner
Name
bioMérieux Inc
Short Name
bioMérieux Inc
Address
100 Rodolphe Street, Durham,, North Carolina 27712, UNITED STATES
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)
VITEK 2 60 Module Colorometric VITEK 2 XL Module Colorimetric VITEK 2 Compact 15 VITEK 2 Compact 30 VITEK 2 Compact 60
Model Identifier(s)
27226 27228 27415 27530 27560
About this record

Access comprehensive regulatory information for bioMerieux VITEK 2 Instrument 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 DE0503158 and owned by bioMérieux Inc. The device was registered on May 29, 2019.

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