Australia TGA ARTG record

Audiometer, auditory evoked response

Australia TGA ARTG Registered Device · Paragon Healthcare Pty Ltd · Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) · Class IIa · Started June 09, 2022

Good Name: Paragon Healthcare Pty Ltd - Audiometer, auditory evoked response

Device classification

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

Registration information

Start Date: June 09, 2022
Effective Date: June 09, 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

Portable, noninvasive device for screening the hearing of infants.

About this record

Access comprehensive regulatory information for Audiometer, auditory evoked response in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Paragon Healthcare Pty Ltd, manufactured by Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) in Canada. The device registration started on June 09, 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.