Singapore HSA registration DE0016005

Remel Wellcolex Color Shigella

Singapore flagSingapore·CLASS B IVD·Remel Europe Limited·Registered July 17, 2014
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration information
Registration Number
DE0016005
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product description
Wellcolex* Colour Shigella provides a simple, rapid qualitative procedure for detection and species identification of Shigella present on solid culture media. The Wellcotest* Colour Shigella test has been categorised as highly complex under CLIA.
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)
Disposable Card Tile Wellcolex Colour Shigella
Model Identifier(s)
R30368701 R30858401
About this record

Access comprehensive regulatory information for Remel Wellcolex Color Shigella 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 DE0016005 and owned by Remel Europe Limited. The device was registered on July 17, 2014.

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