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Radio-frequency ablation system generator - ARTG 362254

Access comprehensive regulatory information for Radio-frequency ablation system generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 362254 and sponsored by Reveale Enterprises Pty Ltd, manufactured by F care systems NV in Belgium. The device registration started on April 16, 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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Class IIb
ARTG 362254
Class IIb
Radio-frequency ablation system generator
ARTG ID: 362254
Good Name: Reveale Enterprises Pty Ltd - Radio-frequency ablation system generator
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Intended Purpose

Thermocoagulator using radiofrequency ablation intended for treatment of varicose veins, spider veins, hemorrhoids and anal fistulae, including treatment of the great saphenous vein (vena saphena magna) and small saphenous vein (vena saphena parva).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
362254
Start Date
April 16, 2021
Effective Date
April 16, 2021
Manufacturer
Country
Belgium
Address
Uitbreidlingstraat 42-46, Berchem, 2600