Sleep assessment device - ARTG 375300
Access comprehensive regulatory information for Sleep assessment device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 375300 and sponsored by Compumedics Limited, manufactured by Compumedics Limited in Australia. The device registration started on September 27, 2021.
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.
The Falcon system is intended for use in the recording, displaying, analysis, printing, and storage of human biological parameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The Falcon is designed for ambulatory and mobile operation and can be used in either the patient’s home, the hospital, or other environments, enabling patients to be investigated under as realistic conditions as possible. The Falcon is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Falcon is only to be used under the direction and supervision of a physician, technologist, or clinician. It will not prevent or restore the interruption or loss of any physiological system.