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Singapore HSA registration DE0017605

GENTIAN BECKMAN COULTER CYSTATIN C

Singapore flagSingapore·CLASS B IVD·Gentian AS·Registered November 02, 2015
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration information
Registration Number
DE0017605
Registration Date
November 02, 2015
Retention Due Date
November 01, 2025
Product description
The Cystatin C Immunoassay is an in vitro diagnostic test for quantitative determination of cystatin C in human serum and plasma. The measurement of cystatin C is used in the diagnosis and treatment of renal diseases
Product Owner
Name
Gentian AS
Short Name
Gentian AS
Address
Bjornasveien 5, 1596 Moss Norway, NORWAY
Registrant
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
Model Name(s)
SYNCHRON UDR Kit (12-pack) UniCel DxC 600 PRO, Packaged UniCel DxC 600, Packaged UniCel DxC 800 PRO, Packaged UniCel DxC 800, Packaged Cystatin C Reagent Kit (100ml +20ml) Gentian Cystatin C Calibrator Kit, level 1-6, vials of 1 mL Gentian Cystatin C Control Kit, Low & High, vials of 1 m Packaged System DxC 800 AR DxC 600 AR Packaged System UniCel DxC Synchron Clinical Systems Operating Software/Boot CD v 5.4.08
Model Identifier(s)
442835 A10400 A10405 A10407 A10411 A52761 A52763 A52765 A80377 A82112 B44661
About this record

Access comprehensive regulatory information for GENTIAN BECKMAN COULTER CYSTATIN C 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 DE0017605 and owned by Gentian AS. The device was registered on November 02, 2015.

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