STARKEY DE MEXICO, S.A. DE C.V.

FDA Device Registration & Listing · Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, MX · Registration 3002159143

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
3002159143
FEI Number
3002159143
Entity Name
STARKEY DE MEXICO, S.A. DE C.V.
City/State/Country
Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, MX
Establishment Address
Calle Norte 7 Numero Lote 2 Y 3, Entre Diagonal Lorenzo De La Garza Y Poniente 2, Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas CP 87499, MX
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
N/A
PMA Number
N/A

All Registered Proprietary Names

Starkey Multiflex Tinnitus Technology 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KLW Masker, Tinnitus Ear, Nose, Throat Class 2 874.3400 2013-01-07
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2013-01-28

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
3006544364 STARKEY (Suzhou) Hearing Technology Co, LTD. Guoxiang, Wuzhong District, Suzhou Jiangsu, CN

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3005019184 Sivantos GmbH Erlangen Bavaria, DE
3004929038 Sonova Hearing (Suzhou) Co., Ltd. Suzhou Jiangsu, CN
2182204 GN Hearing Care Corporation Shakopee, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002159143. Last updated year: 2026. Please use registration number 3002159143 when referencing this establishment in official correspondence.
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