BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FRESENIUS HEMOCARE GMBH

    Reg #: 3004634229 · FEI: 3004634229 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    24
    Establishment Types
    3
    Classifications
    6

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    Registration Details

    Registration Name
    FRESENIUS HEMOCARE GMBH
    Registration Number
    3004634229
    FEI Number
    3004634229
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gruener Weg 10
    City
    Friedberg Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K160735

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Apparatus, Autotransfusion CAC
    Set, Transfer (Blood/Plasma) KSB
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Hematocrit, Tube, Rack, Sealer, Holder GHY
    Supplies, Blood-Bank KSS
    Device, Blood Mixing And Blood Weighing KSQ

    Proprietary Names

    CATSmart System COMPODOCK COM.TEC CELL SEPARATOR TPE Plasma Exchange Set Composeal Universal Composeal Mobilea HemoSeal CompoSeal Mobilea II CompoMat G5 Plus and CompoMaster Net G5 Plus AT1 Autotransfusion Set Waste bag 10 L Reinfusion Bag with Y-Adapter ATF 40 Fast Start Kit Reinfusion Bag 1000 mL ATF 120 Fast Start Kit Fresenius CATS Autotransfusion Syst COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM CATSmart DONATION MASTER NT HEMOLIGHT PLUS COMPOGUARD DONATIONMASTER ADVANCE SOFTWARE COMPOGUARD ADVANCE CATSmart, Automated Blood Processing Autotransfusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device