Australia TGA ARTG record

Axonics Neurostimulator - Stimulator, electrical, neuromuscular, incontinence, implantable

Australia TGA ARTG Registered Device · Axonics Modulation Technologies Australia Pty Ltd · Axonics Inc · Class III · Started June 15, 2022

Good Name: Axonics Modulation Technologies Australia Pty Ltd - Axonics Neurostimulator - Stimulator, electrical, neuromuscular, incontinence, implantable

Device classification

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

Registration information

Start Date: June 15, 2022
Effective Date: June 15, 2022

Sponsor

Name: Axonics Modulation Technologies Australia Pty Ltd

Manufacturer

Name: Axonics Inc
Country: United States of America
Address: 26 Technology Drive, Irvine, California, 92618

Intended purpose

The neurostimulator is an implantable device intended to treat urinary and/or faecal incontinence.

About this record

Access comprehensive regulatory information for Axonics Neurostimulator - Stimulator, electrical, neuromuscular, incontinence, implantable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Axonics Modulation Technologies Australia Pty Ltd, manufactured by Axonics Inc in United States of America. The device registration started on June 15, 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.