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Anaesthesia face mask, reusable - ARTG 427654

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 registered under ARTG number 427654 and 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.

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Class IIb
ARTG 427654
Class IIb
Anaesthesia face mask, reusable
ARTG ID: 427654
Good Name: Medline International Two Australia Pty Ltd - Anaesthesia face mask, reusable
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427654
Start Date
November 09, 2023
Effective Date
November 09, 2023
Manufacturer
Country
China
Address
Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026