BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EARP Cuff

    Reg #: 3013480096 · FEI: 3013480096 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARDIEM MEDICAL, INC.
    Registration Number
    3013480096
    FEI Number
    3013480096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1380 Route 286 Hwy E
    City
    Indiana
    State
    PA
    ZIP
    15701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230853

    Owner / Operator

    Firm Name
    Ardiem Medical, inc.
    Operator Number
    10093545
    Address
    1380 Route 286 East, Indiana, PA 15701
    City
    Indiana
    State
    PA
    Postal Code
    15701
    Country
    US
    Correspondent
    Scott Rietscha

    Products

    Device Name Product Code
    Stimulator, Nerve ETN

    Proprietary Names

    EARP Cuff

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)