ARTG 366731RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
ARTG ID: 366731 · Bio-Excel Australia Pty Ltd · Kaneka Corporation · Class III · Started May 20, 2021
Good Name: Bio-Excel Australia Pty Ltd - RAIDEN 3 PTCA Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 366731
- Start Date
- May 20, 2021
- Effective Date
- May 20, 2021
- Country
- Japan
- Address
- 3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288
This product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (PTCA).
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.