BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    C8-5

    Reg #: 3013204397 · FEI: 3013204397 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    5

    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
    K233788

    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
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    C8-5 X6-1 S8-3 XL14-3 3D9-3v BP10-5ec C6-2 S5-1 D2cwc X7-2t L12-5 50 Epiq Ultrasound S4-2 VL13-5 C5-1 eL18-4 X8-2t D2tcd X5-1 L12-3 S7-3t L18-5 C10-4ec Affiniti Ultrasound V6-2 S12-4 X7-2 L15-7io X5-1c X8-2ti D5cwc C10-3v C9-2 C9-4v

    Establishment Types

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