Australia TGA ARTG record

Audio-Smart - Otoacoustic emission system, battery-powered

Australia TGA ARTG Registered Device · AIMedical International Pty Ltd · Neurosoft LLC · Class IIa · Started January 18, 2024

Good Name: AIMedical International Pty Ltd - Audio-Smart - Otoacoustic emission system, battery-powered

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: January 18, 2024
Effective Date: January 18, 2024

Sponsor

Name: AIMedical International Pty Ltd

Manufacturer

Name: Neurosoft LLC
Country: Russia
Address: 5 Voronin Str, Ivanovo, 153032

Intended purpose

 Hearing screening, including newborns (configurations 1-4).  Detection of hearing loss degree (configurations 1, 3, 4).  Detection of electrophysiological threshold of hearing (with ABR using Jewett V marker) (configurations 1, 4).  Middle ear and Eustachian tube disorders (configurations 3, 4, 5). The Audio-SMART system can be used in healthcare and hearing diagnostic centers, maternity centers, ambulatory-care and neurosurgery clinics, testing laboratories of research institutes. The Audio-SMART system is to be used by trained personnel only, such as audiologists, ear-nose-throat (ENT) doctors, pediatricians, and other hearing health care professionals and audiologically trained technicians. The system should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. The Audio-SMART system can be used to diagnose hearing disorders in patients of all ages. When performing the Eustachian tube function (ETF) test, patient should understand the instructions and perform the maneuvers to obtain reliable results.

About this record

Access comprehensive regulatory information for Audio-Smart - Otoacoustic emission system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by AIMedical International Pty Ltd, manufactured by Neurosoft LLC in Russia. The device registration started on January 18, 2024.

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.