BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

    Reg #: 3035708507 · FEI: 3035708507 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pabst Transport GmbH & Co. KG
    Registration Number
    3035708507
    FEI Number
    3035708507
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriestrasse 15
    City
    Gochsheim Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K220721

    Owner / Operator

    Firm Name
    FRESENIUS MEDICAL CARE
    Operator Number
    8010838
    Address
    ELSE KROENER-STRASSE 1, --
    City
    BAD HOMBURG
    State
    Hesse
    Postal Code
    D-61352
    Country
    DE

    US Agent

    Business Name
    VP Regulatory Affairs
    Contact Name
    Denise Oppermann
    Address
    920 Winter St
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479 ext. 0

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device