Australia TGA ARTG recordOpen-surgery electrosurgical 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 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, 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
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.