Pure Global

ECG-D12 - Interpretive multichannel electrocardiograph - ARTG 376185

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 registered under ARTG number 376185 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 376185
Class IIa
ECG-D12 - Interpretive multichannel electrocardiograph
ARTG ID: 376185
Good Name: Visionflex Pty Ltd - ECG-D12 - Interpretive multichannel electrocardiograph
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
376185
Start Date
October 12, 2021
Effective Date
October 12, 2021
Manufacturer
Country
Taiwan
Address
3F No 306/306-3 Sec 1 Datong Rd, Sijhih Dist, New Taipei City, 22146