Singapore HSA registration DE0510547
GENTIAN BECKMAN COULTER CYSTATIN C AU Systems
Singapore·CLASS B IVD·Gentian AS·Registered April 03, 2025Device 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 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.
Product Owner
- Name
- Gentian AS
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD