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Xenios console for extracorporeal circulation - Cardiopulmonary bypass system centrifugal pump drive unit - ARTG 407188

Access comprehensive regulatory information for Xenios console for extracorporeal circulation - Cardiopulmonary bypass system centrifugal pump drive unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 407188 and sponsored by Fresenius Medical Care Australia Pty Ltd, manufactured by Xenios AG in Germany. The device registration started on March 31, 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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TGA ARTG Official Data
Class IIb
ARTG 407188
Class IIb
Xenios console for extracorporeal circulation - Cardiopulmonary bypass system centrifugal pump drive unit
ARTG ID: 407188
Good Name: Fresenius Medical Care Australia Pty Ltd - Xenios console for extracorporeal circulation - Cardiopulmonary bypass system centrifugal pump drive unit
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Intended Purpose

The Xenios console is intended for use in temporary extracorporeal cardiovascular and cardiopulmonary support for patient stabilisation or therapy.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
407188
Start Date
March 31, 2023
Effective Date
March 31, 2023
Manufacturer
Country
Germany
Address
Im Zukunftspark 1, Heilbronn, 74076