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Infusion controller, battery-powered - ARTG 459025

Access comprehensive regulatory information for Infusion controller, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 459025 and sponsored by Edwards Lifesciences Pty Ltd, manufactured by Edwards Lifesciences LLC in United States of America. The device registration started on August 09, 2024.

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
ARTG 459025
Class IIa
Infusion controller, battery-powered
ARTG ID: 459025
Good Name: Edwards Lifesciences Pty Ltd - Infusion controller, battery-powered
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Intended Purpose

Used to track the fluid being administered to the patient when used with a compatible hemodynamic monitoring platform

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
459025
Start Date
August 09, 2024
Effective Date
August 09, 2024
Manufacturer
Country
United States of America
Address
One Edwards Way, Irvine, California, 92614