Australia flagARTG 480813

CPAP/BiPAP face mask, reusable

ARTG ID: 480813 · Plus Medical Pty Ltd · Suzhou Yuyue Medical Technology Co Ltd · Class IIa · Started February 25, 2025

Good Name: Plus Medical Pty Ltd - CPAP/BiPAP face mask, reusable

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
480813
Start Date
February 25, 2025
Effective Date
February 25, 2025
Sponsor
Manufacturer
Country
China
Address
No 9 Jinfeng Road Suzhou Science & Technology Town, Suzhou, Jiangsu, 215163
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.

About this record

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 480813 and sponsored by Plus Medical Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on February 25, 2025.

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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