Pure Global

ASAHI Gaia Next PCI Guide Wire - Catheter guide wire - ARTG 444590

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 registered under ARTG number 444590 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
ARTG 444590
Class III
ASAHI Gaia Next PCI Guide Wire - Catheter guide wire
ARTG ID: 444590
Good Name: Bio-Excel Australia Pty Ltd - ASAHI Gaia Next PCI Guide Wire - Catheter guide wire
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
ARTG ID
444590
Start Date
March 26, 2024
Effective Date
March 26, 2024
Manufacturer
Country
Japan
Address
3-100 Akatsuki-Cho Seto, AICHI, 489-0071