Australia TGA ARTG record

Ikazuchi Zero PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Kaneka Corporation · Class III · Started May 20, 2021

Good Name: Bio-Excel Australia Pty Ltd - Ikazuchi Zero PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device classification

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

Registration information

Start Date: May 20, 2021
Effective Date: May 20, 2021

Sponsor

Name: Bio-Excel Australia Pty Ltd

Manufacturer

Name: Kaneka Corporation
Country: Japan
Address: 3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288

Intended purpose

This product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (PTCA).

About this record

Access comprehensive regulatory information for Ikazuchi Zero PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bio-Excel Australia Pty Ltd, manufactured by Kaneka Corporation in Japan. The device registration started on May 20, 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.