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GUIDEPLUS II - Catheter, intravascular, guiding - ARTG 427647

Access comprehensive regulatory information for GUIDEPLUS II - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 427647 and sponsored by Nipro Australia Pty Ltd, manufactured by Nipro Corporation in Japan. The device registration started on November 09, 2023.

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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Class III
ARTG 427647
Class III
GUIDEPLUS II - Catheter, intravascular, guiding
ARTG ID: 427647
Good Name: Nipro Australia Pty Ltd - GUIDEPLUS II - Catheter, intravascular, guiding
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Intended Purpose

The device is inserted into coronary arteries and used to guide interventional devices, etc. to affected areas in coronary arteries during procedures such as percutaneous transluminal coronary angioplasty. Notably, this product is placed in front of affected areas that are difficult for interventional devices to reach, and then used to support an interventional device.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427647
Start Date
November 09, 2023
Effective Date
November 09, 2023
Manufacturer
Country
Japan
Address
3-9-3 Honjo-nishi, Kita-Ku, Osaka, 531-8510