Pure Global

bioMérieux VIDAS® Mumps IgG - HSA Registration DE0502120

Access comprehensive regulatory information for bioMérieux VIDAS® Mumps IgG 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 DE0502120 and owned by BIOMERIEUX S.A.. The device was registered on September 06, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0502120
bioMérieux VIDAS® Mumps IgG
HSA Registration Number: DE0502120
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

VIDAS Mumps IgG (MPG) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of IgG antibodies to mumps virus in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). This assay is intended as an aid in the diagnosis of mumps and to provide epidemiological information on mumps.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0502120
Registration Date
September 06, 2018
Change Notification Approval Date
June 27, 2020
Retention Due Date
September 05, 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)
VIDAS® Mumps IgG (60 tests/kit)
Model Identifier(s)
30218