Australia flagARTG 392634

Audiometer, auditory evoked response

ARTG ID: 392634 · Paragon Healthcare Pty Ltd · Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) · Class I · Started July 22, 2022

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

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
392634
Start Date
July 22, 2022
Effective Date
July 22, 2022
Sponsor
Manufacturer
Country
Canada
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1
Intended purpose

Accessories for an electroacoustic device that evaluates the activity of the auditory nervous system in response to an acoustic signal at the ear.

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 I is registered under ARTG number 392634 and sponsored by Paragon Healthcare Pty Ltd, manufactured by Natus Medical Incorporated DBA Excel-Tech Ltd (Xltek) in Canada. The device registration started on July 22, 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.

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