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RANDOX CREATININE (CREA) CR8316 - HSA Registration DE0506922

Access comprehensive regulatory information for RANDOX CREATININE (CREA) CR8316 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 DE0506922 and owned by RANDOX LABORATORIES LIMITED. The device was registered on June 02, 2022.

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
DE0506922
RANDOX CREATININE (CREA) CR8316
HSA Registration Number: DE0506922
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Product Description

For the quantitative in vitro determination of Creatinine in serum and urine. This product is suitable for use on the RX series analyser RX daytona plus.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0506922
Registration Date
June 02, 2022
Retention Due Date
June 01, 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)
CREATININE (CREA)
Model Identifier(s)
CR8316