BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fresenius USA Manufacturing, Inc.

    Reg #: 1713747 · FEI: 1713747 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Fresenius USA Manufacturing, Inc.
    Registration Number
    1713747
    FEI Number
    1713747
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    475 WEST 13TH ST.
    City
    Ogden
    State
    UT
    ZIP
    84404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190459

    Owner / Operator

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

    Products

    Device Name Product Code
    Dialyzer, Capillary, Hollow Fiber FJI
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    Hemoflow F4 Dialyzer Hemoflow F3 Dialyzer Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers Optiflux F180NR Dialyzer bibag

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility