Acoustic earmuffs - ARTG 388392
Access comprehensive regulatory information for Acoustic earmuffs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 388392 and sponsored by Paragon Healthcare Pty Ltd, manufactured by Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) in Canada. The device registration started on May 13, 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.
Indicated for short-term (less than 24 hours) hospital use with neonates in a supervised setting to reduce the sound level reaching the neonate’s ears.