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Singapore HSA registration DE0016002

Remel Stained Proteus Suspensions

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
DE0016002
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
Product description
Stained Proteus Suspensions are intended for the quantitative detection of rickettsial antibodies in sera for epidemiological and diagnostic purposes in the investigation of rickettsial infections (Weil-Felix test). Proteus Agglutinating Sera are intended for use as control antisera for Stained Proteus Suspensions (SS16/30953601 to SS18/30953801), in the Weil-Felix test1, for epidemiological and diagnostic purposes.
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)
Febrile Negative Control Proteus OX2 Agglutinating Sera Proteus OX19 Agglutinating Sera Proteus OXK Agglutinating Sera Proteus OX2 Stained Suspensions Proteus OX19 Stained Suspensions Proteus OXK Stained Suspensions
Model Identifier(s)
R30165401 R30165701 R30165801 R30165901 R30953601 R30953701 R30953801
About this record

Access comprehensive regulatory information for Remel Stained Proteus Suspensions 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 DE0016002 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