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Open-surgery electrosurgical electrode, monopolar, single-use

Access comprehensive regulatory information for Open-surgery electrosurgical electrode, monopolar, single-use 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 December 20, 2016.

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 IIb
Class IIb
Open-surgery electrosurgical electrode, monopolar, single-use
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Open-surgery electrosurgical electrode, monopolar, single-use
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Intended Purpose

A sterile, invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 20, 2016
Effective Date
December 20, 2016
Manufacturer
Country
South Korea
Address
Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do