Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012172416

FEI Number

3012172416

Entity Name

Xenios AG

City/State/Country

Heilbronn Baden-Wurttemberg, DE

Establishment Address

Im Zukunftspark 1, Heilbronn Baden-Wurttemberg 74076, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Xenios AG (Owner Number: 10045964)

Owner / Operator Contact Address

Im Zukunftspark 1, Heilbronn, DE-BW 74076, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191407

PMA Number

N/A

All Registered Proprietary Names

Novalung control panel Novalung sensor box Novalung power supply Novalung pump drive DP3 Novalung Console Compact holder XLung kit Extracorporeal system for long-term respiratory / cardiopulmonary failure Trolley N Novalung System Novalung battery pack Trolley N Flow Sensor 3/8x3/32 Support for backup pump drive Novalung console Novalung power supply Novalung control panel Novalung sensor box Infusion Stand compact Novalung System Novalung battery pack Compact holder XLung kit Novalung pump drive DP3 IPS Pressure Sensor connecting cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWF	Tubing, Long Term Support Greater Than 6 Hours	Cardiovascular	Class 2	870.4100	2026-04-07
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	Cardiovascular	Class 2	870.4100	2026-04-07
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Cardiovascular	Class 2	870.4100	2026-04-07
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Cardiovascular	Class 2	870.4100	2020-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

Denise M Oppermann Business: Fresenius Medical Care North America Email: Denise.M.Oppermann@fmc-na.com Phone: (781) 6994479

Related Public Records

Same Entity

Xenios AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030191221	Xenios AG	Reutlingen Baden-Wurttemberg, DE
3002845651	XENIOS AG	Stolberg North Rhine-Westphalia, DE

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3011468686	MC3, Inc.	Dexter, MI, US
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX
3035708507	Pabst Transport GmbH & Co. KG	Gochsheim Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012172416. Last updated year: 2026. Please use registration number 3012172416 when referencing this establishment in official correspondence.