BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Harmonic ACE

    Reg #: 3016832577 · FEI: 3016832577 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Expeditors International BV
    Registration Number
    3016832577
    FEI Number
    3016832577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Conakryweg 1
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K143132

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US
    Correspondent
    Mario Lowe

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Instrument, Ultrasonic Surgical LFL

    Proprietary Names

    Harmonic ACE

    Establishment Types

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