Australia TGA ARTG recordOpen-surgery electrosurgical handpiece/electrode, monopolar, single-use
Australia TGA ARTG Registered Device · Koala Medical Pty Ltd · Bio Protech Inc · Class IIb · Started December 20, 2016
Good Name: Koala Medical Pty Ltd - Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- December 20, 2016
- Effective Date
- December 20, 2016
- Name
- Bio Protech Inc
- Country
- South Korea
- Address
- Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do
A sterile rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a pencil form and has a smoke evacuation feature to support its primary electrosurgical function. This is a single-use device.
Access comprehensive regulatory information for Open-surgery electrosurgical handpiece/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.