Singapore HSA registration DE0510591
OXOID Brilliance™ UTI Clarity
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0510591
- Registration Date
- April 12, 2025
- Retention Due Date
- April 11, 2026
Product description
Brilliance™ UTI Clarity (PO1110A) device is a differential media for the isolation and presumptive differentiation of the common microorganisms causing urinary tract infections (UTIs) and direct identification of E. coli from clinical samples, including urine samples. Brilliance™ UTI Clarity (PO1110A) device is used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having UTIs. The devices are for professional use only, are not automated and nor are they companion diagnostics.
Product Owner
- Name
- Oxoid Ltd
- Short Name
- Oxoid Ltd
- 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)
- Brilliance™ UTI Clarity
- Model Identifier(s)
- PO1110A
About this record
Access comprehensive regulatory information for OXOID Brilliance™ UTI Clarity 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 DE0510591 and owned by Oxoid Ltd. The device was registered on April 12, 2025.
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 B IVD