BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    5008X Hemodialysis System

    Reg #: 3015335038 · FEI: 3015335038 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ERIKA DE REYNOSA, S.A. DE C.V.
    Registration Number
    3015335038
    FEI Number
    3015335038
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MIKE ALLEN 1011, PARQUE INDUSTRIAL REYNOSA
    City
    CD, REYNOSA Tamaulipas
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K231534

    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 9969103

    Products

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

    Proprietary Names

    5008X Hemodialysis System

    Establishment Types

    Manufacture Medical Device