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Perineal orifice incontinence-control electrical stimulation system electrode

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Perineal orifice incontinence-control electrical stimulation system electrode
Australia TGA ARTG Registered Device
Good Name: ACRA Regulatory Services Pty Ltd - Perineal orifice incontinence-control electrical stimulation system electrode
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Intended Purpose

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

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
Manufacturer
Country
Taiwan
Address
3 Fl & 8 Fl No 5 Lane 155 Section 3 Bei-Sheng Road, Shenkeng District, New Taipei City, 22203