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CPAP/BiPAP nasal mask, reusable - ARTG 381651

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 381651 and sponsored by Air Liquide Healthcare Pty Ltd, manufactured by Air Liquide Medical Systems SRL in Italy. The device registration started on January 04, 2022.

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 381651
Class IIa
CPAP/BiPAP nasal mask, reusable
ARTG ID: 381651
Good Name: Air Liquide Healthcare Pty Ltd - CPAP/BiPAP nasal mask, reusable
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Intended Purpose

A mask intended for single-patient reuse in the home environment and multipatient reuse in the hospital environment by adult patients for whom a continuous positive airway pressure therapy (CPAP), Bi-Level positive airway pressure therapy (BiPAP), or a respiratory support with positive expiratory pressure therapy (PEP), has been prescribed.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
381651
Start Date
January 04, 2022
Effective Date
January 04, 2022
Manufacturer
Country
Italy
Address
Via Calabria 31, Milano, 20158