BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EdgeLife Handheld Wireless Ultrasound System (E8200)

    Reg #: 3034232408 · FEI: 3034232408 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EDGE LIFE TECHNOLOGIES, LLC
    Registration Number
    3034232408
    FEI Number
    3034232408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8405 Nw 29th St
    City
    Doral
    State
    FL
    ZIP
    33122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234153

    Owner / Operator

    Firm Name
    Edge Life Technologies, LLC
    Operator Number
    10092096
    Address
    8405 NW 29th St
    City
    Doral
    State
    FL
    Postal Code
    33122
    Country
    US

    Products

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

    Proprietary Names

    EdgeLife Handheld Wireless Ultrasound System (E8200) EdgeLife Handheld Wireless Ultrasound System (E8220)

    Establishment Types

    Manufacture Medical Device