BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    AGITO MEDICAL

    Reg #: 3007562060 · FEI: 3007562060 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    AGITO MEDICAL
    Registration Number
    3007562060
    FEI Number
    3007562060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bejlerholm 3a
    City
    Norresundby Nordjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K221190

    Owner / Operator

    Firm Name
    AGITO Medical A/S
    Operator Number
    10091434
    Address
    Bejlerholm 3B
    City
    Norresundby
    State
    Nordjylland
    Postal Code
    9400
    Country
    DK
    Correspondent
    Christian Frandsen

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Biopsy Needle Guide Kit OIJ
    System, X-Ray, Tomography, Computed JAK
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Collimator, Automatic, Radiographic IZW

    Proprietary Names

    OPTITOP 150/30/50HC-100

    Establishment Types

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