BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OTOMAG BONE CONDUCTION HEARING SYSTEM

    Reg #: 3005820796 · FEI: 3005820796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Eberle GmbH & Co. KG
    Registration Number
    3005820796
    FEI Number
    3005820796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GLASBRONNENSTRASSE 6
    City
    WURMBERG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123962

    Owner / Operator

    Firm Name
    EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG
    Operator Number
    9086231
    Address
    GLASBRONNENSTRASSE 6, --
    City
    WURMBERG
    State
    DE-NOTA
    Postal Code
    D-75449
    Country
    DE

    US Agent

    Business Name
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Contact Name
    GERALDGOIGITZER Goigitzer
    Address
    320 International Pkwy
    City
    Sunrise
    State
    FL
    ZIP
    33325
    Country
    US
    Email
    [email protected]
    Phone
    954 2178780 ext. 0

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    OTOMAG BONE CONDUCTION HEARING SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)