Pure Global

bioMerieux api® Listeria - HSA Registration DE0014274

Access comprehensive regulatory information for bioMerieux api® Listeria 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 DE0014274 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0014274
bioMerieux api® Listeria
HSA Registration Number: DE0014274
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

API Listeria is a standardized system for the identification of Listeria, which uses miniaturized tests, as well as a database.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220010
Registration Information
Registration Number
DE0014274
Registration Date
November 12, 2013
Change Notification Approval Date
July 18, 2022
Retention Due Date
November 11, 2025
Product Owner
Short Name
BIOMERIEUX
Address
Chemin de l'Orme,, 69280 MARCY L ETOILE FRANCE, FRANCE
Registrant
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model Information
Model Name(s)
api® Listeria apiweb™ V 1.2.1 apiweb™ stand alone V 1.2.1 api® M Medium ZYM B api® Suspension Medium, 2 ml McFarland Standard
Model Identifier(s)
10300 40011 40012 50120 70493 70700 70900