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CPAP/BiPAP face mask, reusable - ARTG 472048

Access comprehensive regulatory information for CPAP/BiPAP face 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 472048 and sponsored by Djmed Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on December 06, 2024.

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 472048
Class IIa
CPAP/BiPAP face mask, reusable
ARTG ID: 472048
Good Name: Djmed Pty Ltd - CPAP/BiPAP face mask, reusable
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Intended Purpose

Sleep apnea breathing mask, CPAP/BiPAP masks are used in conjunction with CPAP and BiPAP. The masks are flexible, face and form-shaped devices designed to be placed over a client's nose and mouth to interface with a CPAP or BiPAP unit. They create an airtight seal around the nose and mouth. They are available in various designs and sizes and are stabilized with a head and/or chin strap. This is a reusable device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472048
Start Date
December 06, 2024
Effective Date
December 06, 2024
Sponsor
Manufacturer
Country
China
Address
No 9 Jinfeng Road Suzhou Science & Technology Town, Suzhou, Jiangsu, 215163