Singapore HSA registration DE0510652
Remel Wellcolex™ Colour Salmonella
Singapore·CLASS C IVD·Remel Europe Limited·Registered April 30, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0510652
- Registration Date
- April 30, 2025
- Retention Due Date
- April 29, 2026
Product description
Wellcolex™ Colour Salmonella is a qualitative latex agglutination test for the detection and presumptive serogroup identification of Salmonella isolates from Selenite F broth and solid media. The kit is used in a diagnostic workflow to aid clinicians in treatment options for patients suspected of having bacterial infections. The device is not automated, is for professional use only and is not a companion diagnostic.
Product Owner
- Short Name
- Remel Europe Limited
- Address
- Remel House, Clipper Boulevaard West, Crossways, Dartford, Kent DA2 6PT, 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)
- Wellcolex Colour Salmonella Wellcolex Colour Salmonella
- Model Identifier(s)
- R30858301 R30858302
About this record
Access comprehensive regulatory information for Remel Wellcolex™ Colour Salmonella 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 DE0510652 and owned by Remel Europe Limited. The device was registered on April 30, 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 C IVD