Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Evolution Surgical Pty Ltd · REGER Medizintechnik GmbH · Class IIb · Started May 28, 2024

Good Name: Evolution Surgical Pty Ltd - Electrosurgical system handpiece, hand-controlled, general-purpose, reusable

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

Sponsor

Name: Evolution Surgical Pty Ltd

Manufacturer

Name: REGER Medizintechnik GmbH
Country: Germany
Address: Gewerbestrasse 10, Villingendorf, 78667

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.

About this record

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.