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Electrosurgical diathermy system return electrode, single-use, non-sterile

Access comprehensive regulatory information for Electrosurgical diathermy system return electrode, single-use, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Boston Scientific Pty Ltd, manufactured by Nissha Medical Technologies Ltd in United Kingdom. The device registration started on August 12, 2021.

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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TGA ARTG Official Data
Class IIb
Class IIb
Electrosurgical diathermy system return electrode, single-use, non-sterile
Australia TGA ARTG Registered Device
Good Name: Boston Scientific Pty Ltd - Electrosurgical diathermy system return electrode, single-use, non-sterile
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Intended Purpose

Neutral electrodes are an accessory for monopolar electrosurgery and represent the large area and low impedance contact with the patientโ€™s skin required for returning the electric current to the generator.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 12, 2021
Effective Date
August 12, 2021
Manufacturer
Country
United Kingdom
Address
Torbay Business Park Woodview Road, Paignton, Devon, TQ4 7HP