Australia TGA ARTG record

ASAHI Gaia Next PCI Guide Wire - Catheter guide wire

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Asahi Intecc Co Ltd Medical Division · Class III · Started March 26, 2024

Good Name: Bio-Excel Australia Pty Ltd - ASAHI Gaia Next PCI Guide Wire - Catheter guide wire

Device classification

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

Registration information

Start Date: March 26, 2024
Effective Date: March 26, 2024

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 wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI). This guidewire is not intended for use in the neurovasculature and peripheral vasculature.

About this record

Access comprehensive regulatory information for ASAHI Gaia Next PCI Guide Wire - Catheter guide wire 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 March 26, 2024.

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.