Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd · Biosense Webster Inc · Class III · Started March 20, 2024

Good Name: Johnson & Johnson Medical Pty Ltd - OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 20, 2024
Effective Date: March 20, 2024

Sponsor

Name: Johnson & Johnson Medical Pty Ltd

Manufacturer

Name: Biosense Webster Inc
Country: United States of America
Address: 31 Technology Drive Suite 200, Irvine, California, 92618

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.

About this record

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 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.