Australia TGA ARTG record

ECG-D12 - Interpretive multichannel electrocardiograph

Australia TGA ARTG Registered Device · Visionflex Pty Ltd · BriteMED Technology Inc · Class IIa · Started October 12, 2021

Good Name: Visionflex Pty Ltd - ECG-D12 - Interpretive multichannel electrocardiograph

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: October 12, 2021
Effective Date: October 12, 2021

Sponsor

Name: Visionflex Pty Ltd

Manufacturer

Name: BriteMED Technology Inc
Country: Taiwan
Address: 3F No 306/306-3 Sec 1 Datong Rd, Sijhih Dist, New Taipei City, 22146

Intended purpose

This device intended use is to acquire, display, record and store 12-lead resting electrocardiograms from adult patients’ heart activity by body surface ECG electrodes

About this record

Access comprehensive regulatory information for ECG-D12 - Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Visionflex Pty Ltd, manufactured by BriteMED Technology Inc in Taiwan. The device registration started on October 12, 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.