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Intensive-care ventilator, general-purpose - ARTG 431111

Access comprehensive regulatory information for Intensive-care ventilator, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 431111 and sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Lowenstein Medical Innovation GmBh & Co KG in Germany. The device registration started on December 19, 2023.

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 IIb
ARTG 431111
Class IIb
Intensive-care ventilator, general-purpose
ARTG ID: 431111
Good Name: Lowenstein Medical Australia Pty Ltd - Intensive-care ventilator, general-purpose
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Intended Purpose

elisa 300 / elisa 500 ventilators are designed for the ventilation of adult and paediatric patients. The sphere of application comprises invasive and non-inโ– vasive ventilation, as well as nasal respiratory therapy (high-flow O2 therapy, nasal CPAP and nasal BiLevel).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
431111
Start Date
December 19, 2023
Effective Date
December 19, 2023
Manufacturer
Country
Germany
Address
Weisskirchener Strasse 1, Steinback Taunus, 61449