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Electrosurgical system handpiece, hand-controlled, general-purpose, reusable

Access comprehensive regulatory information for Electrosurgical system handpiece, hand-controlled, general-purpose, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Evolution Surgical Pty Ltd, manufactured by REGER Medizintechnik GmbH in Germany. The device registration started on May 28, 2024.

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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TGA ARTG Official Data
Class IIb
Class IIb
Electrosurgical system handpiece, hand-controlled, general-purpose, reusable
Australia TGA ARTG Registered Device
Good Name: Evolution Surgical Pty Ltd - Electrosurgical system handpiece, hand-controlled, general-purpose, reusable
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Intended Purpose

A hand-held component of an electrosurgical system intended to be used for open or endoscopic surgery. The devices acts as a contact and switching element between the system generator and a detachable electrode at its distal end, the electrode is not included. The device is a pen with detachable cables for connection to the generator; The product must be connected with the appropriate output of the electrosurgical generator and serve to connect the generator with bipolar electrodes. This is a reusable device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 28, 2024
Effective Date
May 28, 2024
Manufacturer
Country
Germany
Address
Gewerbestrasse 10, Villingendorf, 78667