BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Renaflo II Hemofilter - HF 2000

    Reg #: 9615942 · FEI: 1000191953 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Medica S.p.A.
    Registration Number
    9615942
    FEI Number
    1000191953
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    via degli Artigiani, 7
    City
    Medolla Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K000028

    Owner / Operator

    Firm Name
    Medica S.p.A.
    Operator Number
    9040626
    Address
    VIA degli Artigiani 7, --
    City
    MEDOLLA
    State
    Modena
    Postal Code
    41036
    Country
    IT
    Correspondent
    ROSSETTI - ANTONIO

    US Agent

    Business Name
    Medica USA Inc.
    Contact Name
    Greg Collins
    Address
    5610 Rowland Rd
    City
    Minnetonka
    State
    MN
    ZIP
    55343
    Country
    US
    Email
    [email protected]
    Phone
    952 6005763

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    Renaflo II Hemofilter - HF 2000

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device