Pure Global
Singapore HSA registration DE0014275

bioMerieux api® NH

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
DE0014275
Registration Date
November 12, 2013
Change Notification Approval Date
August 08, 2023
Retention Due Date
November 11, 2025
Product description
API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catarrhalis (Branhamella catarrhalis). 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. API® NH also enables the biotyping of Haemophilus influenzae and Haemophilus parainfluenzae, as well as the detection of a penicillinase.
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® NH api® NaCl 0.85% Medium, 2 ml apiweb™ V 1.2.1 apiweb™ stand alone V 1.2.1 MINERAL OIL ZYM B JAMES McFarland Standard
Model Identifier(s)
10400 20070 40011 40012 70100 70493 70542 70900
About this record

Access comprehensive regulatory information for bioMerieux api® NH 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 DE0014275 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