Australia TGA ARTG record

Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Asahi Intecc Co Ltd Medical Division · Class III · Started July 01, 2019

Good Name: Bio-Excel Australia Pty Ltd - Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding

Device classification

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

Registration information

Start Date: July 01, 2019
Effective Date: July 03, 2019

Sponsor

Name: Bio-Excel Australia Pty Ltd

Manufacturer

Name: Asahi Intecc Co Ltd Medical Division
Country: Japan
Address: 3-100 Akatsuki-Cho Seto, AICHI, 489-0071

Intended purpose

This guide catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This guide catheter is not intended for use in cerebral vasculature and peripheral vasculature such as arms and legs.

About this record

Access comprehensive regulatory information for Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding 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 July 01, 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.