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Resuscitator, pulmonary, manual, single use - ARTG 459665

Access comprehensive regulatory information for Resuscitator, pulmonary, manual, 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 459665 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Galemed Xiamen Co Ltd in China. The device registration started on August 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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Class IIb
ARTG 459665
Class IIb
Resuscitator, pulmonary, manual, single use
ARTG ID: 459665
Good Name: Teleflex Medical Australia Pty Ltd - Resuscitator, pulmonary, manual, single use
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Intended Purpose

The manual disposable resuscitator is used to provide air under pressure for patients with severe respiratory distress. The device is composed of a bag, valve and mask and may be connected to supplemental oxygen if required. This is a single use device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
459665
Start Date
August 15, 2024
Effective Date
August 15, 2024
Manufacturer
Country
China
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026