Australia TGA ARTG record

Intensive-care ventilator, general-purpose

Australia TGA ARTG Registered Device · Lowenstein Medical Australia Pty Ltd · Lowenstein Medical Innovation GmBh & Co KG · Class IIb · Started December 19, 2023

Good Name: Lowenstein Medical Australia Pty Ltd - Intensive-care ventilator, general-purpose

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 19, 2023
Effective Date: December 19, 2023

Sponsor

Name: Lowenstein Medical Australia Pty Ltd

Manufacturer

Name: Lowenstein Medical Innovation GmBh & Co KG
Country: Germany
Address: Weisskirchener Strasse 1, Steinback Taunus, 61449

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-in■vasive ventilation, as well as nasal respiratory therapy (high-flow O2 therapy, nasal CPAP and nasal BiLevel).

About this record

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 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.