Australia TGA ARTG recordASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery
Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Asahi Intecc Co Ltd Medical Division · Class III · Started October 21, 2019
Good Name: Bio-Excel Australia Pty Ltd - ASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 21, 2019
- Effective Date
- October 21, 2019
- Country
- Japan
- Address
- 3-100 Akatsuki-Cho Seto, AICHI, 489-0071
This product is a catheter with two lumens : an over-the-wire lumen that extends across the length of the catheter, and a rapid exchange lumen installed at the distal end. It consists of a tip, shaft, protector and connector and is 145cm long. The surface of the distal section of the shaft of this product is coated with hydrophilic coating and a radiopaque marker is provided between the tip and the shaft of the product, enabling the user to view the position of the tip under X-ray fluoroscopy.
Access comprehensive regulatory information for ASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery 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 Asahi Intecc Co Ltd Medical Division in Japan. The device registration started on October 21, 2019.
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.