BEUDAMED
    FDA Registration Active 🇫🇷 France

    Starkey Multiflex Tinnitus Technology

    Reg #: 3004184391 · FEI: 3004184391 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Starkey France S.A.R.L.
    Registration Number
    3004184391
    FEI Number
    3004184391
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23 Rue Claude Nicolas Ledoux, Europarc Batiment 14
    City
    Creteil Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K201370

    Owner / Operator

    Firm Name
    Starkey Laboratories, Inc.
    Operator Number
    2125608
    Address
    6700 Washington Ave S, --
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Brian Dahl

    Products

    Device Name Product Code
    Masker, Tinnitus KLW

    Proprietary Names

    Starkey Multiflex Tinnitus Technology Miracle Ear Custom Tinnitus Starkey Multiflex Tinnitus Pro Miracle Ear Custom Tinnitus +

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device