BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    S&W ECG Electrodes

    Reg #: 8020045 · FEI: 6736 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LEONHARD LANG GMBH
    Registration Number
    8020045
    FEI Number
    6736
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ARCHENWEG 56
    City
    INNSBRUCK Tirol
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K073104

    Owner / Operator

    Firm Name
    LEONHARD LANG GMBH
    Operator Number
    8020045
    Address
    ARCHENWEG 56, --
    City
    INNSBRUCK
    State
    AT-NOTA
    Postal Code
    A-6020
    Country
    AT
    Correspondent
    BURRHUS - LANG

    US Agent

    Business Name
    PALADIN MEDICAL, INC.
    Contact Name
    ELAINE DUNCAN, MS.ME., RAC, AIMBE
    Address
    415 VALLEY VIEW TRAIL
    City
    HOULTON
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Electrode, Electrocardiograph DRX

    Proprietary Names

    S&W ECG Electrodes others Skintact ECG Electrodes

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device