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Remel Wellcolex™ Colour Salmonella - HSA Registration DE0510652

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.

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CLASS C IVD
DE0510652
Remel Wellcolex™ Colour Salmonella
HSA Registration Number: DE0510652
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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.

Device 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 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