Australia TGA ARTG record

Endoscopic electrosurgical electrode, monopolar, single-use

Australia TGA ARTG Registered Device · Reveale Enterprises Pty Ltd · F care systems NV · Class IIb · Started May 26, 2021

Good Name: Reveale Enterprises Pty Ltd - Endoscopic electrosurgical electrode, monopolar, single-use

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

Sponsor

Name: Reveale Enterprises Pty Ltd

Manufacturer

Name: F care systems NV
Country: Belgium
Address: Uitbreidlingstraat 42-46, Berchem, 2600

Intended purpose

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

About this record

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.