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Oxygen administration enhancement device - ARTG 448909

Access comprehensive regulatory information for Oxygen administration enhancement device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 448909 and sponsored by Lateral Medical, manufactured by Hangzhou Formed Medical Devices Co Ltd in China. The device registration started on May 17, 2024.

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
ARTG 448909
Class I
Oxygen administration enhancement device
ARTG ID: 448909
Good Name: Lateral Medical - Oxygen administration enhancement device
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Intended Purpose

Product is intended to provide a visual indication of patient respiration. A non-powered device designed to be attached to a patient airway such as a endotracheal tube or laryngeal mask.. It consists of a small bag which inflates and deflates as the patient breathes, and is typically used during post-surgical recovery and emergency areas as a complementary method of respiration monitoring. This is a non-sterile, single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
448909
Start Date
May 17, 2024
Effective Date
May 17, 2024
Sponsor
Manufacturer
Country
China
Address
Building 3 No 292 Gonghe North Road Xindeng Town Fuyang District, Hangzhou, 311404