ARTG 444051OPTRELL™ Mapping Catheter with TRUEref™ Technology - Electrophysiology cardiac catheter, single-use
ARTG ID: 444051 · 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
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 444051
- Start Date
- March 20, 2024
- Effective Date
- March 20, 2024
- Country
- United States of America
- Address
- 31 Technology Drive Suite 200, Irvine, California, 92618
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.
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.