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bioMérieux VIDAS® CK-MB - HSA Registration DE0502760

Access comprehensive regulatory information for bioMérieux VIDAS® CK-MB 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 DE0502760 and owned by BIOMERIEUX S.A.. The device was registered on February 07, 2019.

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
DE0502760
bioMérieux VIDAS® CK-MB
HSA Registration Number: DE0502760
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Product Description

VIDAS CK-MB is an automated quantitative test for use on the VIDAS family instruments for the quantitative measurement of the MB isoenzyme of human creatine kinase in human serum or plasma (lithium heparin or EDTA), using the ELFA technique (Enzyme Linked Fluorescent Assay).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0502760
Registration Date
February 07, 2019
Retention Due Date
February 06, 2026
Product Owner
Short Name
BIOMERIEUX S.A.
Address
376,, Chemin de l’Orme 69280, Marcy L Etoile, 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)
VIDAS® CK-MB, 30 tests
Model Identifier(s)
30421