BEUDAMED
    FDA Registration Active 🇺🇸 United States

    bibag

    Reg #: 3013546115 · FEI: 3013546115 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Fresenius USA Manufacturing, Inc.
    Registration Number
    3013546115
    FEI Number
    3013546115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5105 South National Drive
    City
    Knoxville
    State
    TN
    ZIP
    37914
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162716

    Owner / Operator

    Firm Name
    Fresenius Medical Care North America
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    bibag

    Establishment Types

    Manufacture Medical Device