Australia TGA ARTG record

Perineal orifice incontinence-control electrical stimulation system electrode

Australia TGA ARTG Registered Device · ACRA Regulatory Services Pty Ltd · Everyway Medical Instruments Co Ltd · Class IIa · Started June 16, 2022

Good Name: ACRA Regulatory Services Pty Ltd - Perineal orifice incontinence-control electrical stimulation system electrode

Device classification

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

Registration information

Start Date: June 16, 2022
Effective Date: June 16, 2022

Sponsor

Name: ACRA Regulatory Services Pty Ltd

Manufacturer

Name: Everyway Medical Instruments Co Ltd
Country: Taiwan
Address: 3 Fl & 8 Fl No 5 Lane 155 Section 3 Bei-Sheng Road, Shenkeng District, New Taipei City, 22203

Intended purpose

A non-implantable neuromuscular electrical stimulator intended to be used for the control of pelvic muscles, for the treatment of urinary incontinence

About this record

Access comprehensive regulatory information for Perineal orifice incontinence-control electrical stimulation system electrode 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 Everyway Medical Instruments Co Ltd in Taiwan. The device registration started on June 16, 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.