Thoracic electrical impedance tomography system - ARTG 477705
Access comprehensive regulatory information for Thoracic electrical impedance tomography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 477705 and sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Timpel S A in Brazil. The device registration started on February 04, 2025.
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.
EIT MODULE is a non-invasive, radiation free medical device intended to generate regional information of changes in ventilation based on electrical impedance data, at the cross section defined by the electrodes placed around the thorax of patients. It provides information in the form of: •Dynamic images; •Ventilation maps; •Realtime impedance, flow, pressure and volume waveforms; •Derived numerical parameters, such as Ventilation Distribution ratios; Intended to assist the qualified and trained healthcare professional in their assessment of the patient’s ventilation at the bedside. Provides an additional source of information to optimize mechanical ventilation, which shall be adjusted within a range of values considered safe by approved protocols and consensus. It does not control the mechanical ventilator, neither substitute the monitoring and alarming of respiratory parameters done either by the ventilator or by a bedside monitor. The device can be used on adult, pediatric and neonatal patients under mechanical ventilation in healthcare facilities.