Singapore HSA registration DE0509404
RANDOX GAMMA-GLUTAMYL TRANSFERASE
Singapore·CLASS B IVD·RANDOX LABORATORIES LIMITED·Registered June 14, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509404
- Registration Date
- June 14, 2024
- Retention Due Date
- June 13, 2025
Product description
A gamma-GT test system is a device intended for the quantitative in vitro determination of L-gamma-Glutamyl transferase (gamma-GT) activity in serum or plasma.
Product Owner
- Short Name
- RANDOX LABORATORIES LIMITED
- Address
- 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, UNITED KINGDOM
Registrant
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-09, SINGAPORE 389842
Importer
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-07/09, SINGAPORE 389842
Model information
- Model Name(s)
- GAMMA-GLUTAMYLTRANSFERASE GAMMA-GLUTAMYLTRANSFERASE GAMMA-GLUTAMYLTRANSFERASE GAMMA-GLUTAMYLTRANSFERASE
- Model Identifier(s)
- GT3817 GT3874 GT523 GT8320
About this record
Access comprehensive regulatory information for RANDOX GAMMA-GLUTAMYL TRANSFERASE 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 DE0509404 and owned by RANDOX LABORATORIES LIMITED. The device was registered on June 14, 2024.
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