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bioMérieux RAPIDEC® CARBA NP - HSA Registration DE0502371

Access comprehensive regulatory information for bioMérieux RAPIDEC® CARBA NP 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 DE0502371 and owned by BIOMERIEUX S.A.. The device was registered on November 23, 2018.

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.

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CLASS C IVD
DE0502371
bioMérieux RAPIDEC® CARBA NP
HSA Registration Number: DE0502371
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Product Description

Rapid test for the detection of carbapenemase-producing Gram-negative bacilli.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0502371
Registration Date
November 23, 2018
Change Notification Approval Date
August 08, 2023
Retention Due Date
November 22, 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 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model Information
Model Name(s)
RAPIDEC® CARBA NP RAPIDEC® CARBA NP
Model Identifier(s)
415418 417498