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SEBIA CAPI 3 URINE - HSA Registration DE0505229

Access comprehensive regulatory information for SEBIA CAPI 3 URINE 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 DE0505229 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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CLASS B IVD
DE0505229
SEBIA CAPI 3 URINE
HSA Registration Number: DE0505229
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Product Description

The CAPI 3 URINE kit is designed for the preparation of human urine samples for analysis with the CAPI 3 URINE procedure with the CAPI 3PROTEIN(E) 6 kit. The CAPI 3 URINE procedure on the CAPILLARYS 3 automated instrument is intended for the qualitative analysis of urinary protein profile to detect abnormalities. For In Vitro Diagnostic Use.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505229
Registration Date
December 09, 2020
Retention Due Date
December 08, 2025
Product Owner
Name
SEBIA
Short Name
SEBIA
Address
Parc Technologique, Lรฉonard de Vinci, CP 8010 โ€“ Lisses, 91008 EVRY CEDEX, FRANCE
Registrant
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
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 PROTEIN(E) 6 CAPI 3 URINE NORMAL CONTROL (5) NORMAL CONTROL (20)
Model Identifier(s)
1245 1246 2503 2513 4785 4786