BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    FRESENIUS KABI AUSTRIA GMBH

    Reg #: 3003708554 · FEI: 3003708554 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    6

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    Registration Details

    Registration Name
    FRESENIUS KABI AUSTRIA GMBH
    Registration Number
    3003708554
    FEI Number
    3003708554
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HAFNERSTRASSE 36
    City
    GRAZ Steiermark
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K211314

    Owner / Operator

    Firm Name
    FRESENIUS KABI DEUTSCHLAND GMBH
    Operator Number
    9097270
    Address
    ELSE-KRONER STRASSE 1, --
    City
    BAD HOMBURG V.D.H.
    State
    DE-NOTA
    Postal Code
    D-61325
    Country
    DE
    Correspondent
    Kanita - Bakija

    US Agent

    Business Name
    Fresenius Kabi GmbH Austria
    Contact Name
    Aparna Dagar
    Address
    3 Corporate Dr
    City
    Deer Park
    State
    IL
    ZIP
    60047
    Country
    US
    Email
    [email protected]
    Phone
    847 5502649

    Products

    Device Name Product Code
    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation QBA
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO
    Set, Perfusion, Kidney, Disposable KDL
    Catheter, Coronary, Atherectomy MCX
    System And Accessories, Isolated Heart, Transport And Preservation MSB
    Catheter, Peripheral, Atherectomy MCW

    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 Catheter, peripheral, atherectomy

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility