Australia TGA ARTG record

Anaesthesia face mask, reusable

Australia TGA ARTG Registered Device · Medline International Two Australia Pty Ltd · Galemed Xiamen Co Ltd · Class IIb · Started November 09, 2023

Good Name: Medline International Two Australia Pty Ltd - Anaesthesia face mask, reusable

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 09, 2023
Effective Date: November 09, 2023

Sponsor

Name: Medline International Two Australia Pty Ltd

Manufacturer

Name: Galemed Xiamen Co Ltd
Country: China
Address: Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026

Intended purpose

Intended to be placed over the nose and mouth to deliver anaesthetic gases to the upper airway. It is made of silicone material that produces a soft, flexible cover to create an airtight seal against the patient's face. This device is sometimes used in association with a manual resuscitator. This is a reusable device.

About this record

Access comprehensive regulatory information for Anaesthesia face mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medline International Two Australia Pty Ltd, manufactured by Galemed Xiamen Co Ltd in China. The device registration started on November 09, 2023.

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.