BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    2008K@HOME HEMODIALYSIS MACHINE

    Reg #: 8030665 · FEI: 3002807744 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ERIKA DE REYNOSA, S.A. DE C.V.
    Registration Number
    8030665
    FEI Number
    3002807744
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MIKE ALLEN 1331, PARQUE INDUSTRIAL REYNOSA
    City
    CD, REYNOSA Tamaulipas
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K070049

    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

    US Agent

    Business Name
    Fresenius Medical Care North America
    Contact Name
    Denise Oppermann
    Address
    920 Winter St.
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479

    Products

    Device Name Product Code
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW

    Proprietary Names

    2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag

    Establishment Types

    Manufacture Medical Device