Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Molnlycke Health Care Pty Ltd · Prima Medical Ltd · Class IIb · Started May 10, 2021

Good Name: Molnlycke Health Care Pty Ltd - Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 10, 2021
Effective Date: May 10, 2021

Sponsor

Name: Molnlycke Health Care Pty Ltd

Manufacturer

Name: Prima Medical Ltd
Country: United Kingdom
Address: The Counting House Bond's Mill Estate, Stonehouse, Gloucestershire, GL 10 3RF

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.

About this record

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 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.