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Angioplasty catheter, balloon dilatation, coronary, basic

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Angioplasty catheter, balloon dilatation, coronary, basic
Australia TGA ARTG Registered Device
Good Name: Bio-Excel Australia Pty Ltd - Angioplasty catheter, balloon dilatation, coronary, basic
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Intended Purpose

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

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
Manufacturer
Country
Japan
Address
3-18 2-Chome Nakanoshima, Kita Ku, Osaka, 530-8288