Australia TGA ARTG recordAnaesthesia face mask, non-scavenging, single-use
Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Shaoxing Undis Medical Technology Co Ltd · Class IIa · Started January 04, 2019
Good Name: Koala Medical Pty Ltd - Anaesthesia face mask, non-scavenging, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- January 04, 2019
- Effective Date
- January 04, 2019
- Country
- China
- Address
- 1F Building No2 Kechuang Zhongxin No 398 Mahuan Road Binhai Xincheng, Shaoxing, 312366
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.
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.