BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Starkey Global Distribution Center

    Reg #: 3019622583 · FEI: 3019622583 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    172
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    Starkey Global Distribution Center
    Registration Number
    3019622583
    FEI Number
    3019622583
    Status
    Active
    Expiry Year
    2026
    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
    Hearing Aid, Air-Conduction, Prescription ESD
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

    Proprietary Names

    Miracle Ear Custom Tinnitus Starkey Multiflex Tinnitus Technology Miracle Ear Custom Tinnitus + Starkey Multiflex Tinnitus Pro Starkey Muse iQ Starkey Tour MicroTech Signature Series Audibel A4 iQ Starkey Xino SoundGear AMP 2 AUDIGY AGXS GENESIS AI Starkey Signature Series MicroTech Summit Starkey Picasso Audibel Invisibel Synergy MICROTECH MT NXG AI NuEar Signature Series MicroTech MicroLens Synergy NuEar NOW iQ Starkey X Series Amplifon ampli-mini AMPLI-MINI Signature Series KINDsignature Starkey Ignite NuEar SDS NuEar canvas Aries MicroTech portrait Aries Pro NuEar Intro MEMINI Signature Series STARKEY GENESIS AI NuEar iNOW iQ Audibel A4 AUDIBEL INTRIGUE AI Audibel Signature Series MicroTech Propel Audibel Axio Miracle-EarBLISS MEMINI NWL CIC 10 EV ST AUDIOSYNC INTRIGUE AI AudioSync Signature Series Starkey 3 Series NuEar Axio Starkey Evolv AI MicroTech Summit iQ Starkey Axio NUEAR NE NXG AI Starkey Halo iQ Starkey Muse Audibel A4i iQ Starkey SoundLens Synergy MicroTech Kinnect iQ Miracle-EarBLISS MEMINI IIC Audigy AGXs Signature Series AMP NuEar Miniscopic Synergy Audibel DaVinci SoundGear AMP NuEar NOW OuieZen SK SG Miracle Ear MEMINI Starkey Custom Charger StarLink Custom Charger 2 MicroTech Envy AI Miracle-EarCHARGE fullpower custom PWR AV StarLink Mini Remote Microphone Starkey Model S Amplifon AMPLI-CROS KINDstarLink Mikrofon 2 Starkey Standard Charger Starkey Z Series StarLink charger 2 NuEar iNow Miracle-EarLINK Mic+ AV Miracle Ear MECROS Audibel Via Edge AI SoundGear Premium Charger 2 mRIC R Miracle-EarCHARGE fullpower RIC/BTE T AV AMPLITV Streamer Starkey SoundGear Phantom Starkey Wi Series AMPLI-MINI E 7S MicroTech Thrive Amplifon AMPLI-MINI NuEar NE Series AI Audibel A2 Starkey Premium Standard Charger StarLink Edge Remote Microphone SoundGear Remote Microphone MicroTech Kinnect 2 StarLink TV Streamer Starkey livio Starkey G Series AI Miracle-EarLINK Remote Microphone + Audibel A Series AI NuEar Noble AI MicroTech esentia AI Starkey Halo MicroTech Kinnect AudioSync A Series AI Audiosync Aris AI MicroTech esentia Kind KINDvaro Starkey Omega AI Miracle-EarLINK TV Streamer AV MicroTech Model M AMPLI-TV 2 LE ST Miracle-EarCHARGE start RIC/BTE AV Miracle Ear MEENERGY Miracle-EarBLISS RIC R-S Audibel Arc AI Miracle-EarCHARGE start custom AV StarLink Remote Control Miracle-Ear MELINK MIC BL+ LE BRANDED PKG ST OuieZen GS Amplifon AMPLI-POWER Audibel Start Audibel Via AI NuEar Circa MELINK TV STREAMER BL+ LE ST Miracle-EarBLISS MEENERGY ITC R KINDstarLink Edge TV Adapter 2 Miracle-EarBLISS MEMINI Audibel A3i Miracle-EarLINK Remote AV Amplifon REMOTE MICROPHONE 2 2.4 GH LE UNBRANDED ST Amplifon AMPLI-ENERGY NuEar Circa Edge AI SoundGear Premium Custom Charger 2 SoundGear TV Streamer Miracle-Ear MEPOWER Audibel A3 Afflelou Incognito GS Starkey Halo 2 SurfLink Programmer Starkey Premium Custom Charger Starkey Livio Edge AI SoundGear Remote Control 2 StarLink Premium Standard Charger 2 Audibel A4i Miracle-EarBLISS MECONNECT BTE 13 POWER PLUS NuEar Circa AI NuEar Edge AI NuEar Savant AI Miracle-EarCHARGE fullpower RIC/BTE PWR AV Starkey Edge AI StarLink Remote Control 2 Miracle-EarLINK Remote Mic AV OuieZen SK ED MicroTech Esentia Edge AI Audiosync Edge AI Audibel Aris AI NuEar Model N MyDo M iQ Miracle Ear MECONNECT Miracle-EarBLISS MEENERGY RIC R Afflelou Incognito Edge AI Afflelou Incognito OM AI Audibel Model A Audigy AGXS Edge AI OuieZen OM Miracle-EarBLISS MEENERGY CROS RIC R Audibel Vitality AI Amplifon ampli-energy StarLink Premium Custom Charger 2 Miracle-EarBLISS MEEASY BTE 13 POWER PLUS Audibel Via StarLink Edge TV Streamer StarLink Remote Microphone + Amplifon AMPLI-CONNECT Miracle-EarBLISS MEENERGY BTE R Starkey livio AI

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device