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ASAHI Gaia Next PCI Guide Wire - Catheter guide wire

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.

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TGA ARTG Official Data
Class III
Class III
ASAHI Gaia Next PCI Guide Wire - Catheter guide wire
Australia TGA ARTG Registered Device
Good Name: Bio-Excel Australia Pty Ltd - ASAHI Gaia Next PCI Guide Wire - Catheter guide wire
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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.

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
Manufacturer
Country
Japan
Address
3-100 Akatsuki-Cho Seto, AICHI, 489-0071