Australia TGA ARTG record

Clinical chemistry substrate IVDs

Australia TGA ARTG Registered Device · AA-Med Pty Ltd · Taidoc Technology Corporation · Class IIb · Started September 22, 2021

Good Name: AA-Med Pty Ltd - Clinical chemistry substrate IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: September 22, 2021
Effective Date: September 22, 2021

Sponsor

Name: AA-Med Pty Ltd

Manufacturer

Name: Taidoc Technology Corporation
Country: Taiwan
Address: B1-7F No 127 Wugong 2nd Road Wugu Dist, New Taipei City, 24888

Intended purpose

The Pops One Blood Glucose Monitoring System is intended for use outside the body(in-vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The Pops One Blood Glucose Monitoring System is comprised of the Pops One blood glucose meter, the Pops One blood glucose sensor module, POPs! Control Solution and the Pops mobile application as the display component. The Pops One Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is not intended for the diagnosis of, or screening of, diabetes. It is not intended for use on neonates. The POPS! One Blood Glucose Monitoring System is not suitable for use in healthcare or assisted use settings.

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 sponsored by AA-Med Pty Ltd, manufactured by Taidoc Technology Corporation in Taiwan. The device registration started on September 22, 2021.

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.