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Cardiopulmonary resuscitation mask, single-use

Access comprehensive regulatory information for Cardiopulmonary resuscitation mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Clever First Aid Pty Ltd, manufactured by Guangzhou Athmedic Healthcare Co Ltd in China. The device registration started on December 04, 2020.

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 I
Class I
Cardiopulmonary resuscitation mask, single-use
Australia TGA ARTG Registered Device
Good Name: Clever First Aid Pty Ltd - Cardiopulmonary resuscitation mask, single-use
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Intended Purpose

A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 04, 2020
Effective Date
December 04, 2020
Manufacturer
Country
China
Address
301 Floor 3 Yalanyuan Luoxixincheng Panyu District Guangzhou City, Guangdong Province, 511431