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Anaesthesia face mask, non-scavenging, single-use

Access comprehensive regulatory information for Anaesthesia face mask, non-scavenging, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Koala Medical Pty Ltd, manufactured by Shaoxing Undis Medical Technology Co Ltd in China. The device registration started on January 04, 2019.

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 IIa
Class IIa
Anaesthesia face mask, non-scavenging, single-use
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Anaesthesia face mask, non-scavenging, single-use
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Intended Purpose

The mask is a single use device that is placed over the nose and mouth intended to deliver air/oxygen and anaesthetic gases to a patient's airway undergoing anaesthesia it features an inflatable facial profiled cuff and a hard shell with a hook ring to attach a strap if needed. It is available in various sizes.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 04, 2019
Effective Date
January 04, 2019
Manufacturer
Country
China
Address
1F Building No2 Kechuang Zhongxin No 398 Mahuan Road Binhai Xincheng, Shaoxing, 312366