BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    COCHLEAR BAHA IMPLANT SYSTEM

    Reg #: 3003847101 · FEI: 3003847101 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELOS MEDTECH TIMMERSDALA AB
    Registration Number
    3003847101
    FEI Number
    3003847101
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BACKEDALSVAGEN
    City
    TIMMERSDALA Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K121317

    Owner / Operator

    Firm Name
    ELOS MEDTECH AB
    Operator Number
    9078344
    Address
    BACKEDALSVAGEN, --
    City
    TIMMERSDALA
    State
    Vastra Gotaland
    Postal Code
    SE-541 71
    Country
    SE
    Correspondent
    Nils - Kristensen

    US Agent

    Business Name
    ONYX MEDICAL CORPORATION
    Contact Name
    JODIE GILMORE
    Address
    1800 North Shelby Oaks Drive
    City
    Memphis
    State
    TN
    ZIP
    38134
    Country
    US
    Email
    [email protected]
    Phone
    901 3236699

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction, Implanted MAH

    Proprietary Names

    COCHLEAR BAHA IMPLANT SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)