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Singapore HSA registration DE0504708

RANDOX DIRECT LDL CHOLESTEROL (LDL)

Singapore flagSingapore·CLASS B IVD·RANDOX LABORATORIES LIMITED·Registered July 14, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0504708
Registration Date
July 14, 2020
Retention Due Date
July 13, 2025
Product description
Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in human serum and plasma. CH2656 and CH2657 is suitable for use on the Cobas Mira, Mira-S, Mira Plus, Hitachi 704, 717, 737, 747, 902, 904, 911, 912, 917, Modular P, Synchron CX® 4/5/7/9, LX® 20 and UniCel DxC 600/800 analysers, while CH9702 is suitable for use on the Hitachi 917 and Hitachi Modular P.
Product Owner
Name
RANDOX LABORATORIES LIMITED
Short Name
RANDOX LABORATORIES LIMITED
Address
55 Diamond Road, Crumlin, County Antrim, BT29 4QY, UNITED KINGDOM
Registrant
Name
BIOMEDIX SINGAPORE PTE. LTD.
Address
627A ALJUNIED ROAD, BIZTECH CENTRE, #08-09, SINGAPORE 389842
Importer
Name
BIOMEDIX SINGAPORE PTE. LTD.
Address
627A ALJUNIED ROAD, BIZTECH CENTRE, #08-07/09, SINGAPORE 389842
Model information
Model Name(s)
DIRECT LDL CHOLESTEROL (LDL) DIRECT LDL CHOLESTEROL (LDL) DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (D LDL/HDL CAL) DIRECT LDL CHOLESTEROL (LDL) LIPID CONTROL - LEVEL 1 LIPID CONTROL - LEVEL 2 LIPID CONTROL - LEVEL 3 LIPID CONTROL - LEVEL 1 LIPID CONTROL - LEVEL 2 LIPID CONTROL - LEVEL 3
Model Identifier(s)
CH2656 CH2657 CH2673 CH9702 LE2661 LE2662 LE2663 LE2668 LE2669 LE2670
About this record

Access comprehensive regulatory information for RANDOX DIRECT LDL CHOLESTEROL (LDL) 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 DE0504708 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