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Endoscopic electrosurgical electrode, monopolar, single-use

Access comprehensive regulatory information for Endoscopic electrosurgical 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 Reveale Enterprises Pty Ltd, manufactured by F care systems NV in Belgium. The device registration started on May 26, 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
Endoscopic electrosurgical electrode, monopolar, single-use
Australia TGA ARTG Registered Device
Good Name: Reveale Enterprises Pty Ltd - Endoscopic electrosurgical electrode, monopolar, single-use
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Intended Purpose

Invasive radiofrequency thermocoagulation probes for treatment of anal fistulae. This is a sterile, single use disposable device.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 26, 2021
Effective Date
May 26, 2021
Manufacturer
Country
Belgium
Address
Uitbreidlingstraat 42-46, Berchem, 2600