BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    COM.TEC CELL SEPARATOR

    Reg #: 3004634229 · FEI: 3004634229 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FRESENIUS HEMOCARE GMBH
    Registration Number
    3004634229
    FEI Number
    3004634229
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gruener Weg 10
    City
    Friedberg Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K060734

    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
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN

    Proprietary Names

    COM.TEC CELL SEPARATOR TPE Plasma Exchange Set

    Establishment Types

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