BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Probo Medical Ltd

    Reg #: 3010398867 · FEI: 3010398867 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    18

    Registration Details

    Registration Name
    Probo Medical Ltd
    Registration Number
    3010398867
    FEI Number
    3010398867
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Electron Building, Mount Court; Edison Close; Center; The
    City
    Gloucester Gloucestershire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K190461

    Owner / Operator

    Firm Name
    Probo Medical Ltd
    Operator Number
    10052961
    Address
    Mount Court, Waterwells Business Park
    City
    Gloucester
    State
    Gloucestershire
    Postal Code
    GL2 2FN
    Country
    GB
    Correspondent
    Zack Walker

    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
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, X-Ray, Mobile IZL
    Bronchoscope (Flexible Or Rigid) EOQ
    Endoscope, Accessories, Narrow Band Spectrum NWB
    System, X-Ray, Tomography, Computed JAK
    Catheter, Ultrasound, Intravascular OBJ
    Automated Radiological Image Processing Software QIH
    Full Field Digital, System, X-Ray, Mammographic MUE
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Cystoscope And Accessories, Flexible/Rigid FAJ
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    Philips Achieva MRI GE Logiq E10 Shimadzu MobileDART MAGNETOM AERA Olympus Processor Siemens Somatom Emotion Philips Epiq GE Optima CT GE Senographe Essential Siemens Magnetom Aera GE Optima 9800 Olympus Camera Head GE Voluson S10 Olympus Flexible Scope Carestream DRX GE Healthcare Siemens Definition GE Discovery NM

    Establishment Types

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