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Surgical plume evacuation system filter - ARTG 391750

Access comprehensive regulatory information for Surgical plume evacuation system filter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 391750 and sponsored by GRC Surgical Pty Ltd, manufactured by Bio Protech Inc in South Korea. The device registration started on July 04, 2022.

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
ARTG 391750
Class I
Surgical plume evacuation system filter
ARTG ID: 391750
Good Name: GRC Surgical Pty Ltd - Surgical plume evacuation system filter
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Intended Purpose

Medical device accessory intended to be used as part of a surgical plume evacuation system to entrap particulates/microbes from smoke created through the use of various tissue-burning surgical devices and prevent them from exhausting into ambient air.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
391750
Start Date
July 04, 2022
Effective Date
July 04, 2022
Manufacturer
Country
South Korea
Address
Donghwa Medical Instrument complex 151-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do