BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DIASAFEplusUS

    Reg #: 3035708507 · FEI: 3035708507 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    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
    K231534

    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
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Subsystem, Water Purification FIP

    Proprietary Names

    DIASAFEplusUS

    Establishment Types

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