Singapore HSA registration DE0504702
RANDOX s LDL-EX "SEIKEN" (sLDL)
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
- DE0504702
- Registration Date
- July 14, 2020
- Retention Due Date
- July 13, 2025
Product description
The s LDL-EX “SEIKEN” kit is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma. The s LDL-EX “SEIKEN” test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease’.
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)
- s LDL-EX "SEIKEN" (sLDL) sLDL CALIBRATOR (sLDL CAL) sLDL CONTROL - LEVEL 1 sLDL CONTROL - LEVEL 2 sLDL CONTROL - LEVEL 3
- Model Identifier(s)
- 562616 CH5050 LE5013 LE5014 LE5015
About this record
Access comprehensive regulatory information for RANDOX s LDL-EX "SEIKEN" (sLDL) 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 DE0504702 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