BEUDAMED
    FDA Registration Active 🇫🇷 France

    PROBO MEDICAL SAS

    Reg #: 3035950510 · FEI: 3035950510 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    PROBO MEDICAL SAS
    Registration Number
    3035950510
    FEI Number
    3035950510
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Rue Louis Breguet
    City
    NANTES Loire-Atlantique
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K203128
    PMA Number
    P010025

    Owner / Operator

    Firm Name
    PROBO Medical SAS
    Operator Number
    10086551
    Address
    1 Rue Louis Breguet
    City
    NANTES
    State
    Loire-Atlantique
    Postal Code
    44980
    Country
    FR
    Correspondent
    Julien Boutter

    US Agent

    Business Name
    Probo Medical Inc
    Contact Name
    Jehovany Hernandez
    Address
    9715 Kincaid Dr Ste 1000
    City
    Fishers
    State
    IN
    ZIP
    46037
    Country
    US
    Email
    [email protected]
    Phone
    931 4364550

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Angiographic IZI
    Coil, Magnetic Resonance, Specialty MOS
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Catheter, Ultrasound, Intravascular OBJ
    Automated Radiological Image Processing Software QIH
    System, X-Ray, Stationary KPR
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI

    Proprietary Names

    Ultrasound Processor- EU-ME2 with accessories Keyboard and Pigtail Hologic Selenia Dimensions Mammograph Siemens Symbia T2 Slice Spect Siemens Biograph Horizon 16 GE Lightspeed 7 VCT Philips Medical Breast Coil Philips X7-2t GE Healthcare System, X-Ray, Tomography, Computed Multi Purpose Flex M Coil Philips Coils Philips Medical Probe System Xray Siemens Artis Zee Philips Probe GE Healthcare Probe Philips Coil Siemens MRI Coils GE Voluson

    Establishment Types

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