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Breathing circuit, ventilator, single use

Access comprehensive regulatory information for Breathing circuit, ventilator, 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 September 20, 2022.

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
Breathing circuit, ventilator, single use
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Breathing circuit, ventilator, single use
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DJ Fang

DJ Fang

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Intended Purpose

A disposable single use breathing circuit used to conduct respiratory gases between ventilator/anaesthetic machine and patient.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 20, 2022
Effective Date
September 20, 2022
Manufacturer
Country
China
Address
1F Building No2 Kechuang Zhongxin No 398 Mahuan Road Binhai Xincheng, Shaoxing, 312366