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Thoracic electrical impedance tomography system - ARTG 399558

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 I is registered under ARTG number 399558 and sponsored by Sentec Monitoring Pty Ltd, manufactured by SenTec AG in Switzerland. The device registration started on November 16, 2022.

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 I
ARTG 399558
Class I
Thoracic electrical impedance tomography system
ARTG ID: 399558
Good Name: Sentec Monitoring Pty Ltd - Thoracic electrical impedance tomography system
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Intended Purpose

The LuMonโ„ข Belts are non-sterile, single-patient use accessories, and are intended to be applied on the circumference of the patientโ€™s thorax on intact skin. Sequential application of LuMonโ„ข Belts on a single patient can be repeated for up to 30 cumulative days. The LuMonโ„ข Belts are indicated for use in adults through neonatal patients with selection of an appropriate belt size based on the thorax circumference (underbust girth).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399558
Start Date
November 16, 2022
Effective Date
November 16, 2022
Manufacturer
Country
Switzerland
Address
Kantonsstrasse 14, Landquart, 7302