Pure Global
Singapore HSA registration DE0506711

BIOMERIEUX MYCOPLASMA IST 3

Singapore flagSingapore·CLASS B IVD·BIOMERIEUX S.A.·Registered March 10, 2022
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0506711
Registration Date
March 10, 2022
Change Notification Approval Date
August 18, 2022
Retention Due Date
March 09, 2026
Product description
MYCOPLASMA IST 3 is a manual qualitative and semi-quantitative in vitro diagnostic test for the culture, identification,indicative enumeration and antibiotic susceptibility testing of Mycoplasma hominis and Ureaplasma spp. including Ureaplasma parvum and Ureaplasma urealyticum.It is intended as an aid to diagnosis and prediction of treatment response in adults suspected of having urogenital mycoplasma infection, using urethral swabs, vaginal and cervical swabs, semen and male urine samples. This assay is intended for use in clinical laboratories by laboratory health professionals.
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)
MYCOPLASMA IST 3
Model Identifier(s)
422083
About this record

Access comprehensive regulatory information for BIOMERIEUX MYCOPLASMA IST 3 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 DE0506711 and owned by BIOMERIEUX S.A.. The device was registered on March 10, 2022.

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