BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Achieva

    Reg #: 3008447096 · FEI: 3008447096 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ELSMED LTD.
    Registration Number
    3008447096
    FEI Number
    3008447096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 Hamagshimim Street, Kiryat Matalon
    City
    Petah Tikva Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K193215

    Owner / Operator

    Firm Name
    Elsmed Ltd.
    Operator Number
    10034154
    Address
    20 Hamagshimim Street, Kiryat Matalon
    City
    Petah Tikva
    State
    IL-NOTA
    Postal Code
    49250
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI

    Proprietary Names

    Achieva Ingenia Intera

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device