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Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set - ARTG 476078

Access comprehensive regulatory information for Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 476078 and sponsored by Fresenius Medical Care Australia Pty Ltd, manufactured by Xenios AG in Germany. The device registration started on January 17, 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 III
ARTG 476078
Class III
Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set
ARTG ID: 476078
Good Name: Fresenius Medical Care Australia Pty Ltd - Novalung kits (XLung kit 230, MiniLung kit 1/4", MiniLung petite) - Cardiopulmonary bypass system tubing set
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Intended Purpose

The Novalung kit range (XLung, MiniLung, MiniLung petite) is intended for long-term respiratory/cardiopulmonary support through the extracorporeal gas exchange, pumping and thermoregulation of blood in patients with acute respiratory or cardiopulmonary distress or failure

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
476078
Start Date
January 17, 2025
Effective Date
January 17, 2025
Manufacturer
Country
Germany
Address
Im Zukunftspark 1, Heilbronn, 74076