BEUDAMED
    FDA Registration Active 🇨🇳 China

    STARKEY (Suzhou) Hearing Technology Co, LTD.

    Reg #: 3006544364 · FEI: 3006544364 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    172
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    STARKEY (Suzhou) Hearing Technology Co, LTD.
    Registration Number
    3006544364
    FEI Number
    3006544364
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1st Floor and East Unit of 2nd Floor, Building 1, No. 588, Shenjiawan Road
    City
    Guoxiang, Wuzhong District, Suzhou Jiangsu
    Country
    CN

    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
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Hearing Aid, Air-Conduction, Prescription ESD
    Masker, Tinnitus KLW

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device