Singapore HSA registration DE0504703
RANDOX FRUCTOSAMINE (FRUC)
Singapore·CLASS B IVD·RANDOX LABORATORIES LIMITED·Registered July 14, 2020Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0504703
- Registration Date
- July 14, 2020
- Retention Due Date
- July 13, 2025
Product description
Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human 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)
- FRUCTOSAMINE CALIBRATOR (FRUC CAL) FRUCTOSAMINE CONTROL - LEVEL 1 FRUCTOSAMINE CONTROL - LEVEL 3 FRUCTOSAMINE (FRUC)
- Model Identifier(s)
- FR2993 FR2994 FR2996 FR3133
About this record
Access comprehensive regulatory information for RANDOX FRUCTOSAMINE (FRUC) 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 DE0504703 and owned by RANDOX LABORATORIES LIMITED. The device was registered on July 14, 2020.
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