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Singapore HSA registration DE0505234

SEBIA CAPI 3 CDT-IFCC

Singapore flagSingapore·CLASS B·SEBIA·Registered December 09, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0505234
Registration Date
December 09, 2020
Retention Due Date
December 08, 2025
Product description
The CAPI 3 CDT kit is designed for the separation of the transferrin isoforms in human serum and the quantification of the disialotransferrin fraction ("CDT-IFCC") by capillary electrophoresis in alkaline buffer (pH 8.8) with the CAPILLARYS 3 instrument. CDT (carbohydrate deficient transferrin) is used as a biomarker of chronic moderate to heavy alcohol consumption
Product Owner
Name
SEBIA
Short Name
SEBIA
Address
Parc Technologique, Léonard de Vinci, CP 8010 – Lisses, 91008 EVRY CEDEX, FRANCE
Registrant
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
Model Name(s)
CAPILLARYS 3 OCTA CAPILLARYS 3 TERA CAPILLARYS / MINICAP CDT SAMPLES TREATMENT SOLUTION CAPI 3 CDT - IFCC procedure CDT CAPILLARYS CALIBRATORS (2 LEVELS) HIGH CDT CONTROL NORMAL CDT CONTROL
Model Identifier(s)
1245 1246 2054 2509 4760 4772 4795
About this record

Access comprehensive regulatory information for SEBIA CAPI 3 CDT-IFCC in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505234 and owned by SEBIA. The device was registered on December 09, 2020.

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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