BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    DELCON SRL

    Reg #: 3014345398 · FEI: 3014345398 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    27
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DELCON SRL
    Registration Number
    3014345398
    FEI Number
    3014345398
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Zanica 19/F/I
    City
    Grassobbio Bergamo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    BK170085

    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
    Barbara Sala

    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
    Supplies, Blood-Bank KSS
    Device, Mixing And Weighing, Semi-Automated MYJ
    Device, Heat-Sealing KSD

    Proprietary Names

    GIO.MZ.WIFI.P2 - GIOTTO MONZA, Automatic blood components extractor. Double press. Wi-Fi version HMIX4.42 Milano Basic version (Gulf Coast) HMIX42 Milano Standard version (white/gray) HMIX41 Milano RFID version (white/gray) HMIX4.32 Milano standard version (Versiti) HMIX4.21 Milano RFID version (white/red) HMIX4.22 Milano Standard version (white/red) HMIX4.31 Milano RFID version (Versiti) HMIX4.41 Milano RFID version (Gulf Coast) HMIX3.WIFI.RFID Blood collection monitor (Version with WiFi and integrated RFID options installed) HMIX3.LAN.RFID Blood collection monitor (Version with LAn and integrated RFID oprions installed) 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 Blood collection monitor (Version with LAN option installed) HWELD-T.DB0 HemoWeld-T Bench tube sealer for medical PVC tubes HWG21 HemoWeld Gun Handgun HWELD-B.DB0 HemoWeld-B - Mobile tube sealer for medical PVC tubes HWG20V HemoWeld-Gun Portable sealer for blood bag tubes - Case Kit HWG20H HemoWeld-Gun Portable sealer for blood bag tubes - Holder Kit HWG22 HemoWeld Gun Power Unit HWELDC.DB0 HemoWeld-Slim Sterile tube bench top sealer HWELD-B.DB0G WELD B - Mobile tube sealer for medical PVC tubes HWONE.CORE1 ROMA Cordless handheld sealer for blood bag tubing and charger HWG20 HemoWeld-Gun HWONE1 ROMA Cordless handheld sealer for blood bag tubing ACC000066 ROMA charger

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)