Somfit System - Sleep assessment device - ARTG 367790
Access comprehensive regulatory information for Somfit System - 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 367790 and sponsored by Compumedics Limited, manufactured by Compumedics Limited in Australia. The device registration started on June 01, 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 Somfit 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 to assist in the diagnosis of various sleep disorders or neurological disorders. The Somfit is designed for use in a home, hospital or other clinical environments. The Somfit is only to be used under the direction of a physician. Note: This intended use specifically excludes use of the Somfit as life support equipment, for example vital signs monitoring in intensive care unit.