Australia flagARTG 390437

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

ARTG ID: 390437 · 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
ARTG ID
390437
Start Date
June 15, 2022
Effective Date
June 15, 2022
Sponsor
Manufacturer
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 registered under ARTG number 390437 and 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.

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