BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    HMC Premedical S.p.A.

    Reg #: 3012667060 · FEI: 3012667060 · Expires 2026
    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
    2026
    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
    3408 Rexford Cir
    City
    Ormond Beach
    State
    FL
    ZIP
    32174
    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