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Open-surgery electrosurgical electrode, monopolar, single-use - ARTG 444950

Access comprehensive regulatory information for Open-surgery electrosurgical electrode, monopolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 444950 and sponsored by Gytech Pty Ltd, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on March 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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Class IIa
ARTG 444950
Class IIa
Open-surgery electrosurgical electrode, monopolar, single-use
ARTG ID: 444950
Good Name: Gytech Pty Ltd - Open-surgery electrosurgical electrode, monopolar, single-use
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Intended Purpose

The device is used during a procedure where a small segment of the cervix is removed and sent to pathology for testing

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
444950
Start Date
March 28, 2024
Effective Date
March 28, 2024
Sponsor
Manufacturer
Country
United States of America
Address
100 West Industrial Road, Addison, Illinois, 60101