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Open-surgery electrosurgical handpiece/electrode, monopolar, single-use - ARTG 365170

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 registered under ARTG number 365170 and sponsored by Molnlycke Health Care Pty Ltd, manufactured by Prima Medical Ltd in United Kingdom. The device registration started on May 10, 2021.

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 IIb
ARTG 365170
Class IIb
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
ARTG ID: 365170
Good Name: Molnlycke Health Care Pty Ltd - Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
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Intended Purpose

The device is intended to be used as the active Monopolar electrode in an electrosurgery generator system, with the additional function to facilitate of removal of surgical smoke, a common by product of electrosurgical procedures.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
365170
Start Date
May 10, 2021
Effective Date
May 10, 2021
Manufacturer
Country
United Kingdom
Address
The Counting House Bond's Mill Estate, Stonehouse, Gloucestershire, GL 10 3RF