Australia flagARTG 338078

CPAP/BiPAP nasal mask, reusable

ARTG ID: 338078 · Lowenstein Medical Australia Pty Ltd · Lowenstein Medical Technology GmbH Co Kg · Class IIa · Started June 18, 2020

Good Name: Lowenstein Medical Australia Pty Ltd - CPAP/BiPAP nasal mask, reusable

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
338078
Start Date
June 18, 2020
Effective Date
June 18, 2020
Sponsor
Manufacturer
Country
Germany
Address
Kronsaalsweg 40, Hamburg, 22525
Intended purpose

A flexible form shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP)

About this record

Access comprehensive regulatory information for CPAP/BiPAP nasal mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 338078 and sponsored by Lowenstein Medical Australia Pty Ltd, manufactured by Lowenstein Medical Technology GmbH Co Kg in Germany. The device registration started on June 18, 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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