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Singapore HSA registration DE0014278

bioMerieux api® 20 E

Singapore flagSingapore·CLASS C IVD·BIOMERIEUX S.A.·Registered November 12, 2013
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0014278
Registration Date
November 12, 2013
Change Notification Approval Date
August 08, 2023
Retention Due Date
November 11, 2025
Product description
API® 20 E is a qualitative standardized system for the identification of Enterobacteriaceae and other non-fastidious Gram-negative rods. It uses miniaturized tests as well as a specially adapted database. Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.
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.
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
Model Name(s)
api® 20 E API 20 E™ REAGENT kit api® Suspension Medium, 5 ml apiweb™ apiweb™ stand alone api® OF Medium api® M Medium Oxidase Reagent MINERAL OIL Zn TDA JAMES VP A + VP B
Model Identifier(s)
20100 20120 20150 40011 40012 50110 50120 55635 70100 70380 70402 70542 70572
About this record

Access comprehensive regulatory information for bioMerieux api® 20 E 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 DE0014278 and owned by BIOMERIEUX S.A.. The device was registered on November 12, 2013.

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