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CPAP/BiPAP nasal mask, reusable - ARTG 338078

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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TGA ARTG Official Data
Class IIa
ARTG 338078
Class IIa
CPAP/BiPAP nasal mask, reusable
ARTG ID: 338078
Good Name: Lowenstein Medical Australia Pty Ltd - CPAP/BiPAP nasal mask, reusable
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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)

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
Manufacturer
Country
Germany
Address
Kronsaalsweg 40, Hamburg, 22525