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Basic endotracheal tube, single-use

Access comprehensive regulatory information for Basic endotracheal tube, 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 June 13, 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
Basic endotracheal tube, single-use
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Basic endotracheal tube, single-use
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Intended Purpose

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. This device is packaged with a connector that will attach to a breathing circuit or manual resuscitator, has a distal inflatable cuff to seal against the tracheal wall, is radiopaque and has a built-in pilot balloon for cuff pressure monitoring. It is made of plastic they are available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 13, 2019
Effective Date
June 13, 2019
Manufacturer
Country
China
Address
1F Building No2 Kechuang Zhongxin No 398 Mahuan Road Binhai Xincheng, Shaoxing, 312366