BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    COMBI 40+ Cochlear Implant System

    Reg #: 9710014 · FEI: 3000249315 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Registration Number
    9710014
    FEI Number
    3000249315
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FUERSTENWEG 77A
    City
    INNSBRUCK Tirol
    Country
    AT

    Regulatory Submissions

    PMA Number
    P000025

    Owner / Operator

    Firm Name
    MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH
    Operator Number
    9042031
    Address
    Fuerstenweg 77a
    City
    Innsbruck
    State
    Tirol
    Postal Code
    6020
    Country
    AT

    US Agent

    Business Name
    MED-EL CORPORATION
    Contact Name
    Valerie Eastwood
    Address
    2645 Meridian Parkway, Suite 100
    City
    DURHAM
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    919 3547514

    Products

    Device Name Product Code
    Implant, Cochlear MCM
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification PGQ

    Proprietary Names

    COMBI 40+ Cochlear Implant System Maestro Cochlear Implant System

    Establishment Types

    Manufacture Medical Device