Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030191221

FEI Number

3030191221

Entity Name

Xenios AG

City/State/Country

Reutlingen Baden-Wurttemberg, DE

Establishment Address

Ferdinand-Lassalle-Strasse 18, Reutlingen Baden-Wurttemberg 72770, 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

K232926

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

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

Official Correspondent

No official correspondent registered.

US Agent Details

Denise Oppermann Business: Fresenius Medical Care North America Email: denise.m.oppermann@freseniusmedicalcare.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
3012172416	Xenios AG	Heilbronn Baden-Wurttemberg, DE
3002845651	XENIOS AG	Stolberg North Rhine-Westphalia, DE

Similar Registrations

Registration Number	Establishment Name	Location
3012172416	Xenios AG	Heilbronn Baden-Wurttemberg, DE
9611665	Sterigenics EO Canada, Inc.	Mississauga Ontario, CA
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 3030191221. Last updated year: 2026. Please use registration number 3030191221 when referencing this establishment in official correspondence.