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RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic - ARTG 366731

Access comprehensive regulatory information for RAIDEN 3 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 registered under ARTG number 366731 and 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.

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TGA ARTG Official Data
Class III
ARTG 366731
Class III
RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
ARTG ID: 366731
Good Name: Bio-Excel Australia Pty Ltd - RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
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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).

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
366731
Start Date
May 20, 2021
Effective Date
May 20, 2021
Manufacturer
Country
Japan
Address
3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288