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RANDOX s LDL-EX "SEIKEN" (sLDL) - HSA Registration DE0504702

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.

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CLASS B IVD
DE0504702
RANDOX s LDL-EX "SEIKEN" (sLDL)
HSA Registration Number: DE0504702
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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’.

Device 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 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