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Resuscitator face mask, single-use - ARTG 468886

Access comprehensive regulatory information for Resuscitator face mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 468886 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Galemed Xiamen Co Ltd in China. The device registration started on November 15, 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 IIb
ARTG 468886
Class IIb
Resuscitator face mask, single-use
ARTG ID: 468886
Good Name: Teleflex Medical Australia Pty Ltd - Resuscitator face mask, single-use
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Intended Purpose

A non-sterile, anatomically-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator. It has an air cushion will create a gastight seal against the face. It will be directly attached to the resuscitator and held in place on the patient's face by a head strap. This is a single-use device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
468886
Start Date
November 15, 2024
Effective Date
November 15, 2024
Manufacturer
Country
China
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026