Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003708554

FEI Number

3003708554

Entity Name

FRESENIUS KABI AUSTRIA GMBH

City/State/Country

GRAZ Steiermark, AT

Establishment Address

HAFNERSTRASSE 36, GRAZ Steiermark A-8055, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

FRESENIUS KABI DEUTSCHLAND GMBH (Owner Number: 9097270)

Owner / Operator Contact Address

ELSE-KRONER STRASSE 1, --, BAD HOMBURG V.D.H., DE-NOTA D-61325, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211314

PMA Number

N/A

All Registered Proprietary Names

Normothermic preservation system for transplantation of initially unacceptable donor lungsNormothermic machine perfusion SET, PERFUSION, KIDNEY, DISPOSABLE CATHETER, CORONARY, ATHERECTOMY MSB- System and accessories, isolated heart, transport and preservation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBA	Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation	Unknown	Class 3	N/A	2019-11-11
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Unknown	Class 3	N/A	2019-11-11
KDL	Set, Perfusion, Kidney, Disposable	Gastroenterology, Urology	Class 2	876.5880	2007-01-30
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2014-05-19
MSB	System And Accessories, Isolated Heart, Transport And Preservation	Gastroenterology, Urology	Class 2	876.5880	2025-12-12

Official Correspondent

Kanita Bakija

US Agent Details

Aparna Dagar Business: Fresenius Kabi GmbH Austria Email: aparna.dagar@fresenius-kabi.com Phone: (847) 5502649

Related Public Records

Same Entity

FRESENIUS KABI DEUTSCHLAND GMBH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003708554. Last updated year: 2026. Please use registration number 3003708554 when referencing this establishment in official correspondence.