BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Family of DIMAR DIMAX NIV masks

    Reg #: 3012667060 · FEI: 3012667060 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HMC Premedical S.p.A.
    Registration Number
    3012667060
    FEI Number
    3012667060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Galileo Galilei, 6
    City
    Medolla Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K232836

    Owner / Operator

    Firm Name
    HMC Group
    Operator Number
    9041724
    Address
    Via Bosco 1/3, --
    City
    Mirandola
    State
    Modena
    Postal Code
    41037
    Country
    IT
    Correspondent
    Danilo Bosetti

    US Agent

    Business Name
    ISOPLAN USA
    Contact Name
    Lorenzo Da Madice
    Address
    1 Festiva Street 38
    City
    Daytona Beach
    State
    FL
    ZIP
    32124
    Country
    US
    Email
    [email protected]
    Phone
    386 8680618

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Family of DIMAR DIMAX NIV masks

    Establishment Types

    Manufacture Medical Device