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Electrosurgical system, general-purpose

Access comprehensive regulatory information for Electrosurgical system, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by CosTec Pty Ltd, manufactured by Nor'ester Medical LLC in United States of America. The device registration started on September 15, 2020.

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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Class IIb
Class IIb
Electrosurgical system, general-purpose
Australia TGA ARTG Registered Device
Good Name: CosTec Pty Ltd - Electrosurgical system, general-purpose
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Intended Purpose

This device is intended for the treatment of spider veins or telangiectasia by thermocoagulation. The system operates a high frequency current to produce a heating effect causing tissue disruption. The system comprises of a generator with monitoring functions, a pen-like stylus with single use electrode and footswitch.

Device Classification
Risk Class
Class IIb
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
September 15, 2020
Effective Date
September 15, 2020
Sponsor
Manufacturer
Country
United States of America
Address
2 Pine Grove Avenue, Lincoln, Rhode Island, 02865