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Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding - ARTG 319477

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 registered under ARTG number 319477 and 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.

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TGA ARTG Official Data
Class III
ARTG 319477
Class III
Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding
ARTG ID: 319477
Good Name: Bio-Excel Australia Pty Ltd - Asahi Hyperion Coronary Guide Catheters - Catheter, intravascular, guiding
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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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
319477
Start Date
July 01, 2019
Effective Date
July 03, 2019
Manufacturer
Country
Japan
Address
3-100 Akatsuki-Cho Seto, AICHI, 489-0071