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Audiometer, auditory evoked response

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 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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TGA ARTG Official Data
Class I
Class I
Audiometer, auditory evoked response
Australia TGA ARTG Registered Device
Good Name: Paragon Healthcare Pty Ltd - Audiometer, auditory evoked response
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 22, 2022
Effective Date
July 22, 2022
Sponsor
Manufacturer
Country
Canada
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1