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Catheter-balloon inflator, reusable - ARTG 482287

Access comprehensive regulatory information for Catheter-balloon inflator, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482287 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Corporation in Japan. The device registration started on March 12, 2025.

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 I
ARTG 482287
Class I
Catheter-balloon inflator, reusable
ARTG ID: 482287
Good Name: Fujifilm Australia Pty Ltd - Catheter-balloon inflator, reusable
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Intended Purpose

This product is the tube kit used in combination with our balloon controller in medical facilities.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482287
Start Date
March 12, 2025
Effective Date
March 12, 2025
Manufacturer
Country
Japan
Address
26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620