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GENTIAN BECKMAN COULTER CYSTATIN C AU Systems - HSA Registration DE0510547

Access comprehensive regulatory information for GENTIAN BECKMAN COULTER CYSTATIN C AU Systems 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 DE0510547 and owned by Gentian AS. The device was registered on April 03, 2025.

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
DE0510547
GENTIAN BECKMAN COULTER CYSTATIN C AU Systems
HSA Registration Number: DE0510547
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Product Description

The Gentian Cystatin C Immunoassay is an immunoturbidimetric assay intended for the in vitro quantitative determination of cystatin C in human serum and plasma on automated clinical analysers by laboratory professional users. The measurement of cystatin C is used in the diagnosis and treatment of renal diseases.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510547
Registration Date
April 03, 2025
Retention Due Date
April 02, 2026
Product Owner
Short Name
Gentian AS
Address
Bjornasveien 5, 1596 Moss Norway, NORWAY
Registrant
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model Information
Model Name(s)
Gentian Cystatin C Calibrator Kit, level 1-6, vials of 1 mL Gentian Cystatin C Control Kit, Low & High, vials of 1 m Gentian Cystatin C Reagent Kit
Model Identifier(s)
A52763 A52765 B08179