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Ventilator, adult - ARTG 477486

Access comprehensive regulatory information for Ventilator, adult in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 477486 and sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Lowenstein Medical Innovation GmBh & Co KG in Germany. The device registration started on February 03, 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.

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Class IIb
ARTG 477486
Class IIb
Ventilator, adult
ARTG ID: 477486
Good Name: Lowenstein Medical Australia Pty Ltd - Ventilator, adult
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Intended Purpose

The device is designed for adult, paediatric, and neonatal patients requiring ventilation support. The range of application covers invasive and noninvasive ventilation by mask or helmet as well as nasal respiratory therapy (Highflow 02 therapy, nasal CPAP and nasal Bilevel). There are no known contraindications. It is the user's responsibility to select appropriate settings in consideration of the clinical situation of the ventilated patient, periodically review these settings and adapt them when necessary. When combined with an application system for volatile anaesthetic agents, the device can also be used as an anaesthesia workstation.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
477486
Start Date
February 03, 2025
Effective Date
February 03, 2025
Manufacturer
Country
Germany
Address
Weisskirchener Strasse 1, Steinback Taunus, 61449