Australia TGA ARTG record

Perineal orifice incontinence-control electrical stimulator, home-use

Australia TGA ARTG Registered Device · ACRA Regulatory Services Pty Ltd · Verity Medical Ltd · Class IIa · Started June 22, 2022

Good Name: ACRA Regulatory Services Pty Ltd - Perineal orifice incontinence-control electrical stimulator, home-use

Device classification

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

Registration information

Start Date: June 22, 2022
Effective Date: June 22, 2022

Sponsor

Name: ACRA Regulatory Services Pty Ltd

Manufacturer

Name: Verity Medical Ltd
Country: Ireland
Address: Churchtown House, Tagoat, Co Wexford, Y35 XY44

Intended purpose

A battery powered electrical stimulator intended to be used to stimulate the muscles and nerve fibres in the pelvic area and is indicated for use: pelvic pain, back pain, stress incontinence, overactive bladder and faecal incontinence

About this record

Access comprehensive regulatory information for Perineal orifice incontinence-control electrical stimulator, home-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by ACRA Regulatory Services Pty Ltd, manufactured by Verity Medical Ltd in Ireland. The device registration started on June 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.