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Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use - ARTG 474926

Access comprehensive regulatory information for Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 474926 and sponsored by Life Systems Medical Pty Ltd, manufactured by Baylis Medical Technologies Inc in Canada. The device registration started on January 03, 2025.

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 III
ARTG 474926
Class III
Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use
ARTG ID: 474926
Good Name: Life Systems Medical Pty Ltd - Nykanen Radiofrequency Wire Kit - Endoscopic electrosurgical electrode, monopolar, single-use
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Intended Purpose

The Nykanen Radiofrequency Wire is intended to create an atrial septal defect in the heart. The intended use of the Connector Cable is to connect the RFP-100A Generator to separately cleared compatible RF devices.

Device Classification
Risk Class
Class III
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
474926
Start Date
January 03, 2025
Effective Date
January 03, 2025
Manufacturer
Country
Canada
Address
2645 Matheson Blvd East, Mississauga, Ontario, L4W 5S4