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Perineal orifice incontinence-control electrical stimulator, home-use

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.

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Class IIa
Class IIa
Perineal orifice incontinence-control electrical stimulator, home-use
Australia TGA ARTG Registered Device
Good Name: ACRA Regulatory Services Pty Ltd - Perineal orifice incontinence-control electrical stimulator, home-use
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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

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
Manufacturer
Country
Ireland
Address
Churchtown House, Tagoat, Co Wexford, Y35 XY44