BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ELESTA SPA

    Reg #: 3015077548 · FEI: 3015077548 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    ELESTA SPA
    Registration Number
    3015077548
    FEI Number
    3015077548
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Arsiero Salvanti 43
    City
    Calenzano Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K260632

    Owner / Operator

    Firm Name
    Elesta SPA
    Operator Number
    10059916
    Address
    Via Baldanzese 17
    City
    Calenzano
    State
    Firenze
    Postal Code
    50041
    Country
    IT
    Correspondent
    Alessia Blundo

    US Agent

    Business Name
    CDI MED GROUP BDA Immeka Medical
    Contact Name
    Roberto Ponceleon
    Address
    6953 Nw 115th Ct
    City
    Doral
    State
    FL
    ZIP
    33178
    Country
    US
    Email
    [email protected]
    Phone
    786 8121211

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Biopsy Needle FCG
    Instrument, Biopsy KNW
    Medical Device Data System OUG
    Needle, Aspiration And Injection, Disposable GAA

    Proprietary Names

    LASER THERMAL THERAPY KIT ECHOLASER X4 ESI INTRODUCER NEEDLE

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device