Pure Global

RANDOX ALKALINE PHOSPHATASE - HSA Registration DE0509403

Access comprehensive regulatory information for RANDOX ALKALINE PHOSPHATASE 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 DE0509403 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0509403
RANDOX ALKALINE PHOSPHATASE
HSA Registration Number: DE0509403
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and plasma.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509403
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)
ALKALINE PHOSPHATASE ALKALINE PHOSPHATASE ALKALINE PHOSPHATASE
Model Identifier(s)
AP3802 AP3803 AP8302