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ASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery - ARTG 325184

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 registered under ARTG number 325184 and sponsored by Bio-Excel Australia Pty Ltd, manufactured by Asahi Intecc Co Ltd 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.

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TGA ARTG Official Data
Class III
ARTG 325184
Class III
ASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery
ARTG ID: 325184
Good Name: Bio-Excel Australia Pty Ltd - ASAHI SASUKE Double Lumen Catheter (RX/OTW) - Catheter, infusion, coronary artery
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Intended Purpose

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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
325184
Start Date
October 21, 2019
Effective Date
October 21, 2019
Manufacturer
Country
Japan
Address
3-100 Akatsuki-Cho Seto, AICHI, 489-0071