Australia TGA ARTG record

ASAHI GLADIUS PTCA Guide Wires - Catheter guide wire

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Asahi Intecc Co Ltd Medical Division · Class III · Started June 22, 2022

Good Name: Bio-Excel Australia Pty Ltd - ASAHI GLADIUS PTCA Guide Wires - Catheter guide wire

Device classification

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

Registration information

Start Date: June 22, 2022
Effective Date: June 22, 2022

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

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

About this record

Access comprehensive regulatory information for ASAHI GLADIUS PTCA Guide Wires - 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 June 22, 2022.

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.