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Oxoid Brilliance VRE Agar - HSA Registration DE0509501

Access comprehensive regulatory information for Oxoid Brilliance VRE Agar 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 DE0509501 and owned by OXOID Limited. The device was registered on July 08, 2024.

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
DE0509501
Oxoid Brilliance VRE Agar
HSA Registration Number: DE0509501
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Product Description

BrillianceTM VRE Agar is a qualitative chromogenic screening medium for the detection of Vancomycin Resistant Enterococci (VRE) from rectal or faecal samples. Brilliance VRE Agar is used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having bacterial infections. The device is for professional use only, is not automated nor is it a companion diagnostic.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0509501
Registration Date
July 08, 2024
Retention Due Date
July 07, 2025
Product Owner
Short Name
OXOID Limited
Address
Wade Road, Basingstoke, Hampshire, RG24 8PW, UNITED KINGDOM
Registrant
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model Information
Model Name(s)
Brillianceโ„ข VRE Agar
Model Identifier(s)
PO1175A