Australia flagARTG 302191

Clinical chemistry substrate IVDs

ARTG ID: 302191 · Point Of Care Diagnostics Australia Pty Ltd · Bionime Corporation · Class IIb · Started April 23, 2018

Good Name: Point Of Care Diagnostics Australia Pty Ltd - Clinical chemistry substrate IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
302191
Start Date
April 23, 2018
Effective Date
April 23, 2018
Sponsor
Manufacturer
Country
Taiwan
Address
No 100 Sec2 Daqing Street South Dist, Taichung City, Taichung City, 40242
Intended purpose

Blood glucose monitoring system/test strips to be used for the quantitative measurement of glucose (sugar) in fresh capillary, venous, arterial, and neonatal whole blood samples. Fresh capillary samples may be drawn from the fingertip, palm and forearm, and in the case of neonates, the heel.

About this record

Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 302191 and sponsored by Point Of Care Diagnostics Australia Pty Ltd, manufactured by Bionime Corporation in Taiwan. The device registration started on April 23, 2018.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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