Australia TGA ARTG record

Endoscopic electrosurgical electrode, bipolar, single-use

Australia TGA ARTG Registered Device · Evolution Surgical Pty Ltd · REGER Medizintechnik GmbH · Class IIb · Started May 22, 2024

Good Name: Evolution Surgical Pty Ltd - Endoscopic electrosurgical electrode, bipolar, single-use

Device classification

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

Registration information

Start Date: May 22, 2024
Effective Date: May 22, 2024

Sponsor

Name: Evolution Surgical Pty Ltd

Manufacturer

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

Intended purpose

A electrode intended to deliver electrosurgical current in a bipolar configuration to tissues for cutting/coagulation/ablation during endoscopic (e.g. arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe). This is a single-use device intended to be used in a sterile condition.

About this record

Access comprehensive regulatory information for Endoscopic electrosurgical electrode, bipolar, single-use 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 22, 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.