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CPAP/BiPAP face mask, single-use

Access comprehensive regulatory information for CPAP/BiPAP face mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Lowenstein Medical Technology GmbH Co Kg in Germany. The device registration started on September 11, 2020.

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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TGA ARTG Official Data
Class IIa
Class IIa
CPAP/BiPAP face mask, single-use
Australia TGA ARTG Registered Device
Good Name: Lowenstein Medical Australia Pty Ltd - CPAP/BiPAP face mask, single-use
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Intended Purpose

A non sterile, flexible, form shaped device designed to be placed over a users nose and mouth to interface with CPAP or BPAP unit to provide the respiratory tract with direct ambient air, or medical oxygen and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 11, 2020
Effective Date
September 11, 2020
Manufacturer
Country
Germany
Address
Kronsaalsweg 40, Hamburg, 22525