Australia TGA ARTG record

Acoustic earmuffs

Australia TGA ARTG Registered Device · Paragon Healthcare Pty Ltd · Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) · Class I · Started May 13, 2022

Good Name: Paragon Healthcare Pty Ltd - Acoustic earmuffs

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 13, 2022
Effective Date: May 13, 2022

Sponsor

Name: Paragon Healthcare Pty Ltd

Manufacturer

Name: Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek)
Country: Canada
Address: 2568 Bristol Circle, Oakville, Ontario, L6H 5S1

Intended purpose

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.

About this record

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 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.