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Singapore HSA registration DE0508428

SEBIA HYDRAGEL BENCE JONES

Singapore flagSingapore·CLASS B IVD·SEBIA·Registered August 26, 2023
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0508428
Registration Date
August 26, 2023
Retention Due Date
August 25, 2025
Product description
The HYDRAGEL 1 BENCE JONES, HYDRAGEL 2 BENCE JONES, HYDRAGEL 4 BENCE JONES and HYDRAGEL 9 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins, monoclonal free light chains kappa or lambda, in human urine or serum, by immunofixation electrophoresis. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies. 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)
HYDRASYS 2 SCAN FOCUSING FREE ANTI-KAPPA 1 mL (SM) FREE ANTI-LAMBDA 1 mL (SM) HYDRAGEL 1 BENCE JONES (SM) HYDRAGEL 2 BENCE JONES (SM) HYDRAGEL 4 BENCE JONES (SM) (GAM. K. L) ANTISERA AND FIXATIVE SOLUTION BOX (SM) K & L FREE LIGHT CHAINS ANTISERA BOX (SM) HYDRAGEL 9 BENCE JONES (SM) MAXI-KIT
Model Identifier(s)
1202 4610 4611 4821 4822 4824 4835 4836 4883
About this record

Access comprehensive regulatory information for SEBIA HYDRAGEL BENCE JONES 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 DE0508428 and owned by SEBIA. The device was registered on August 26, 2023.

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