BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Xario 200

    Reg #: 3013204397 · FEI: 3013204397 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Modality Group Ltd
    Registration Number
    3013204397
    FEI Number
    3013204397
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 56 Hayhill Industrial Estate, 47 Hayhill
    City
    Barrow upon Soar Leicestershire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K143027

    Owner / Operator

    Firm Name
    Modality Group Ltd
    Operator Number
    10053163
    Address
    Fosse House, 20 Prince William Road
    City
    Loughborough
    State
    Leicestershire
    Postal Code
    LE11 5GU
    Country
    GB
    Correspondent
    Carl Bowtell

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Xario 200 PSU-25BT PSU-30BT PSU-50BT PVU-375BT PVU-382BT PVU-674BT PVU-674MV PVU-712BT PVU-745BTF PVU-745BTH PVU-745BTV PVU-681MVL PVU-770ST PVU-781VT PVL-715RS PLU-704BT PLU-1005BT PLU-1204BT PET-512MC PET-805LA PC-20M PC-50M

    Establishment Types

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