Australia TGA ARTG record

Angioplasty catheter, balloon dilatation, coronary, basic

Australia TGA ARTG Registered Device · Bio-Excel Australia Pty Ltd · Kaneka Corporation · Class IIa · Started August 03, 2021

Good Name: Bio-Excel Australia Pty Ltd - Angioplasty catheter, balloon dilatation, coronary, basic

Device classification

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

Registration information

Start Date: August 03, 2021
Effective Date: August 03, 2021

Sponsor

Name: Bio-Excel Australia Pty Ltd

Manufacturer

Name: Kaneka Corporation
Country: Japan
Address: 3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288

Intended purpose

This device is intended to be used in percutaneous transluminal coronary angioplasty (PTCA) to facilitate the exchange of catheters.

About this record

Access comprehensive regulatory information for Angioplasty catheter, balloon dilatation, coronary, basic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Bio-Excel Australia Pty Ltd, manufactured by Kaneka Corporation in Japan. The device registration started on August 03, 2021.

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.