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Airway, oropharyngeal, single use

Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Shaoxing Undis Medical Technology Co Ltd · Class IIa · Started March 13, 2020

Good Name: Koala Medical Pty Ltd - Airway, oropharyngeal, single use

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
March 13, 2020
Effective Date
March 13, 2020
Sponsor
Manufacturer
Country
China
Address
1F Building No2 Kechuang Zhongxin No 398 Mahuan Road Binhai Xincheng, Shaoxing, 312366
Intended purpose

A plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device works by preventing the tongue from obstructing airflow. This device is single use.

About this record

Access comprehensive regulatory information for Airway, oropharyngeal, 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 March 13, 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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