RANDOX ALDOLASE - HSA Registration DE0509408
Access comprehensive regulatory information for RANDOX ALDOLASE 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 DE0509408 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.
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HSA Official Data
CLASS B IVD
DE0509408
RANDOX ALDOLASE
HSA Registration Number: DE0509408
Product Description
For the quantitative in vitro determination of Aldolase in serum.
Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509408
Registration Date
June 14, 2024
Retention Due Date
June 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)
ALDOLASE (ALS)
ALDOLASE CALIBRATOR
ALDOLASE CONTROL LEVEL 2
ALDOLASE CONTROL LEVEL 3
Model Identifier(s)
AD189
AD5000
AD5001
AD5002