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Electrosurgical diathermy system return electrode, single-use, non-sterile

Access comprehensive regulatory information for Electrosurgical diathermy system return electrode, single-use, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Koala Medical Pty Ltd, manufactured by Bio Protech Inc in South Korea. The device registration started on February 07, 2017.

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 IIb
Class IIb
Electrosurgical diathermy system return electrode, single-use, non-sterile
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Electrosurgical diathermy system return electrode, single-use, non-sterile
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Intended Purpose

A non-sterile non-active dispersive conductor intended to be fastened to a patient using an adhesive gel pad and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. The Pro Plate is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached cables but may be provided without one allowing the use of a reusable cable. This is a single-use device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 07, 2017
Effective Date
February 07, 2017
Manufacturer
Country
South Korea
Address
Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do