BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Starkey Multiflex Tinnitus Technology

    Reg #: 3019622583 · FEI: 3019622583 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Starkey Global Distribution Center
    Registration Number
    3019622583
    FEI Number
    3019622583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3810 Plainfield Road, Suite#112
    City
    Plainfield
    State
    IN
    ZIP
    46168
    Country
    US

    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

    Repack or Relabel Medical Device Manufacture Medical Device