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OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use - ARTG 444051

Access comprehensive regulatory information for OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, 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 444051 and sponsored by Johnson & Johnson Medical Pty Ltd, manufactured by Biosense Webster Inc in United States of America. The device registration started on March 20, 2024.

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 III
ARTG 444051
Class III
OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use
ARTG ID: 444051
Good Name: Johnson & Johnson Medical Pty Ltd - OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use
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Intended Purpose

The OPTRELL™ Mapping Catheter with TRUEref™ Technology is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
444051
Start Date
March 20, 2024
Effective Date
March 20, 2024
Manufacturer
Country
United States of America
Address
31 Technology Drive Suite 200, Irvine, California, 92618