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Singapore HSA registration DE0016004

Remel Streptex Test Kits

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
DE0016004
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product description
Streptex* is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
Product Owner
Name
Remel Europe Limited
Short Name
Remel Europe Limited
Address
Remel House, Clipper Boulevaard West, Crossways, Dartford, Kent DA2 6PT, UNITED KINGDOM
Registrant
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
Name
THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Address
33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
Model Name(s)
Streptex Polyvalent Positive Control Streptex Kit Streptex Reaction Card Tiles Streptex Kit Streptex Rapid Streptex Latex Group A Streptex Latex Group B Streptex Latex Group C Streptex Latex Group D Streptex Extraction Enzyme Streptex Latex Group F Streptex Latex Group G Streptex Acid Extraction Kit
Model Identifier(s)
R30164601 R30164701 R30368601 R30950501 R30950555 R30950601 R30950701 R30950801 R30950901 R30951001 R30951101 R30951201 R30951301
About this record

Access comprehensive regulatory information for Remel Streptex Test Kits 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 DE0016004 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