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Thoracic electrical impedance tomography system - ARTG 460286

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 460286 and sponsored by Bellavista Medical ANZ Pty Ltd, manufactured by Timpel S A in Brazil. The device registration started on August 21, 2024.

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 IIa
ARTG 460286
Class IIa
Thoracic electrical impedance tomography system
ARTG ID: 460286
Good Name: Bellavista Medical ANZ Pty Ltd - Thoracic electrical impedance tomography system
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Intended Purpose

The Timpel Enlight 2100 EIT is a non-invasive, radiation free medical device intended to generate regional information of changes in lung ventilation & lung perfusion based on electrical impedance data, defined by the electrodes placed around the thorax of the patients.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460286
Start Date
August 21, 2024
Effective Date
August 21, 2024
Manufacturer
Country
Brazil
Address
Rua Jose Leonardi 280 Bloco A, Aeroporto, Pato Branco, Parana, 85 503-000