Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019622583

FEI Number

3019622583

Entity Name

Starkey Global Distribution Center

City/State/Country

Plainfield, IN, US

Establishment Address

3810 Plainfield Road, Suite#112, Plainfield, IN 46168, US

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

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	2020-06-26
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-06-12

Official Correspondent

Brian Dahl

US Agent Details

No US Agent registered (Local establishment).

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
2183732	STARKEY GLENCOE	GLENCOE, MN, US
3002159143	STARKEY DE MEXICO, S.A. DE C.V.	Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, MX
3006544364	STARKEY (Suzhou) Hearing Technology Co, LTD.	Guoxiang, Wuzhong District, Suzhou Jiangsu, CN

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

Similar Registrations

Registration Number	Establishment Name	Location
3026390997	AURELIYM GMBH	Bad Neuenahr-Ahrweiler Rhineland-Palatinate, DE
3002808415	Unitron Hearing, a division of National Hearing Services Inc.	KITCHENER Ontario, CA
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 3019622583. Last updated year: 2026. Please use registration number 3019622583 when referencing this establishment in official correspondence.