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Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs

Access comprehensive regulatory information for Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Plexus RA Pty Ltd, manufactured by Bionime Corporation in Taiwan. The device registration started on April 19, 2013.

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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Class IIb
Class IIb
Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs
Australia TGA ARTG Registered Device
Good Name: Plexus RA Pty Ltd- Clinical chemistry substrate IVDs
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Intended Purpose

The blood glucose monitoring system is used by individuals with diabetes. It is for the checking on glucose levels in capillary whole blood, as an aid in management of diabetes at home and clinical sites.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
April 19, 2013
Effective Date
March 15, 2019
Manufacturer
Country
Taiwan
Address
No 100 Sec2 Daqing Street South Dist, Taichung City, Taichung City, 40242