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Electrosurgical unit, endotherapy

Access comprehensive regulatory information for Electrosurgical unit, endotherapy in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Promis Medical Australia Pty Ltd, manufactured by Zerone Co Ltd in South Korea. The device registration started on August 09, 2013.

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
Electrosurgical unit, endotherapy
Australia TGA ARTG Registered Device
Good Name: Promis Medical Australia Pty Ltd - Electrosurgical unit, endotherapy
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Intended Purpose

Intended to cut and coagulate tissue using high frequency current for use with an endoscope. This is the external electrosurgical unit only.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
August 09, 2013
Effective Date
August 09, 2013
Manufacturer
Country
South Korea
Address
Shinil IT UTO Bldg Dangjeong-dong #810 LS-ro 13, Gunpo-si, Gyeonggi-do