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Evacuator, smoke, surgical

Access comprehensive regulatory information for Evacuator, smoke, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Koala Medical Pty Ltd, manufactured by Bio Protech Inc in South Korea. The device registration started on November 08, 2019.

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 I
Class I
Evacuator, smoke, surgical
Australia TGA ARTG Registered Device
Good Name: Koala Medical Pty Ltd - Evacuator, smoke, surgical
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Intended Purpose

A device that is used to capture the smoke generated during open surgical procedures in which there is tissue ablation, e.g. laser surgery, electrocautery or electrosurgery. It captures the smoke plume composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue near its origin before the smoke becomes air-dispersed and enters the respiratory tracts of the surgical team. The device may also be used during closed surgical procedures, e.g. endoscopy or laparoscopy, to clear smoke from the surgeon's field of view.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 08, 2019
Effective Date
November 08, 2019
Manufacturer
Country
South Korea
Address
Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do