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RANDOX GLUTAMATE DEHYDROGENASE (GLDH) - HSA Registration DE0509406

Access comprehensive regulatory information for RANDOX GLUTAMATE DEHYDROGENASE (GLDH) 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 DE0509406 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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CLASS B IVD
DE0509406
RANDOX GLUTAMATE DEHYDROGENASE (GLDH)
HSA Registration Number: DE0509406
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Product Description

For the quantitative in vitro determination of Glutamate Dehydrogenase (GLDH) in serum.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509406
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)
GLUTAMATE DEHYDROGENASE (GLDH) GLUTAMATE DEHYDROGENASE (GLDH)
Model Identifier(s)
GL441 GL442