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

Australia TGA ARTG Registered Device · Getz Healthcare Pty Ltd · Prima Medical Ltd · Class IIb · Started September 30, 2019

Good Name: Getz Healthcare 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
September 30, 2019
Effective Date
September 30, 2019
Sponsor
Manufacturer
Country
United Kingdom
Address
No 1 Business Centre No 1 Alvin Street, Gloucester, GL1 3EJ
Intended purpose

An electrosurgical handpiece/electrode intended to be used as the active monopolar electrode in an electrosurgery generator system, used in a number of different electrosurgical procedures. In addition to this, when connected to a smoke evacuation and filter unit, the device facilitates the removal of harmful “surgical smoke” from the operative site without the use of a separate device.

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 Getz Healthcare Pty Ltd, manufactured by Prima Medical Ltd in United Kingdom. The device registration started on September 30, 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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