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Singapore HSA registration DE0505232

SEBIA CAPI 3 HB A1C

Singapore flagSingapore·CLASS B IVD·SEBIA·Registered December 09, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0505232
Registration Date
December 09, 2020
Retention Due Date
December 08, 2025
Product description
The CAPI 3 Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 instrument. The CAPILLARYS 3 instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of HbA1c fraction. The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. Quantitative determination of hemoglobin A1c is effective in monitoring middle-term blood glucose control in diabetic individuals. Quantitative measurement of hemoglobin A1c can be used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus. For In Vitro Diagnostic Use
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 CAPI 3 Hb A1c Hb A1c CAPILLARY CALIBRATORS (2 levels) HbA1c CAPILLARY CALIBRATORS (5x2) MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2) MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)
Model Identifier(s)
1245 1246 2515 4755 4756 4767 4768
About this record

Access comprehensive regulatory information for SEBIA CAPI 3 HB A1C 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 DE0505232 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD