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Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Access comprehensive regulatory information for Open-surgery electrosurgical handpiece/electrode, monopolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by GRC Surgical Pty Ltd, manufactured by Zhejiang Medstar Technology Co Ltd in China. The device registration started on August 04, 2022.

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
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Australia TGA ARTG Registered Device
Good Name: GRC Surgical Pty Ltd - Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
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DJ Fang

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Intended Purpose

To be used to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. When used with an effective smoke evacuation system, removes smoke plume from the surgical site.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 04, 2022
Effective Date
August 04, 2022
Manufacturer
Country
China
Address
1F Building 1 No 239 Yatai Road Nanhu District Jiaxing City, Zhejiang, 314050