STARKEY (Suzhou) Hearing Technology Co, LTD.

FDA Device Registration & Listing · Guoxiang, Wuzhong District, Suzhou Jiangsu, CN · Registration 3006544364

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006544364
FEI Number
3006544364
Entity Name
STARKEY (Suzhou) Hearing Technology Co, LTD.
City/State/Country
Guoxiang, Wuzhong District, Suzhou Jiangsu, CN
Establishment Address
1st Floor and East Unit of 2nd Floor, Building 1, No. 588, Shenjiawan Road, Guoxiang, Wuzhong District, Suzhou Jiangsu 215124, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Starkey Laboratories, Inc. (Owner Number: 2125608)
Owner / Operator Contact Address
6700 Washington Ave S, --, Eden Prairie, MN 55344, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201370
PMA Number
N/A

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2013-01-28
ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat Class 1 874.3300 2007-06-12
KLW Masker, Tinnitus Ear, Nose, Throat Class 2 874.3400 2020-06-26

Official Correspondent

Brian Dahl

US Agent Details

Brian Dahl Email: regulatory@starkey.com Phone: (952) 9474858

Related Public Records

Same Entity

Starkey Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2125608 Starkey Laboratories, Inc. EDEN PRAIRIE, MN, US
3019622583 Starkey Global Distribution Center Plainfield, IN, US
2183732 STARKEY GLENCOE GLENCOE, MN, US
3002159143 STARKEY DE MEXICO, S.A. DE C.V. Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K892457 Telstar Electronics, Inc. TELSTAR MODEL 1/3 ITE HEARING AID 1989-06-06
K760996 Unitron Industries, Inc. HEARING AID (MODEL 695D, 905 & 960P) 1976-11-16
K840825 Maico Hearing Instruments, Inc. SERIES MR IN-THE-EAR CUSTOM HEARING AID 1984-03-30
K946253 Maico Hearing Instruments, Inc. MAICO IN-THE-EAR MODEL RD 201 1995-01-30
K863975 Gn Danavox, Inc. CUSTOM IN-THE-EAR 1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006544364. Last updated year: 2026. Please use registration number 3006544364 when referencing this establishment in official correspondence.
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