BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    HMIX3.485 Blood collection monitor (Basic version)

    Reg #: 3014345398 · FEI: 3014345398 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DELCON SRL
    Registration Number
    3014345398
    FEI Number
    3014345398
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Zanica 19/F/I
    City
    Grassobbio Bergamo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    BK180229

    Owner / Operator

    Firm Name
    Delcon Srl
    Operator Number
    10057182
    Address
    Via Zanica 19/F/I
    City
    Grassobbio
    State
    Bergamo
    Postal Code
    24050
    Country
    IT
    Correspondent
    Fabio Belletti

    US Agent

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

    Products

    Device Name Product Code
    Device, Mixing And Weighing, Semi-Automated MYJ

    Proprietary Names

    HMIX3.485 Blood collection monitor (Basic version) HMIX3.WIFI Blood collection monitor (Version with WiFi option installed) HMIX3.485.RFID Blood collection monitor (Version with internal RFID option installed) HMIX3.LAN.RFID Blood collection monitor (Version with LAn and integrated RFID oprions installed) HMIX3.LAN Blood collection monitor (Version with LAN option installed) HMIX3.WIFI.RFID Blood collection monitor (Version with WiFi and integrated RFID options installed)

    Establishment Types

    Manufacture Medical Device