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Starkey Laboratories Inc.

United States·US-MF-000014382

Last updated June 8, 2026

Information

Country: United States
Address: 6700, Washington Ave South, Eden Prairie, Minnesota, United States
Website: starkey.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800 328 8602
PRRC Contact: Brian Dahl
EUDAMED SRN: US-MF-000014382
FDA FEI Number: —
DUNS Number: —

Catalogue (5591)

Page 17 of 112

Device	Model / Reference	Registries	Class	Status
Nuear	Now Prestige Wrls BTE 13	FDA UDI	Class II	Active
Audiosync	(DEMO) AUDIOSYNC ARC AI 2400 BTE 13	FDA UDI	Class II	Active
Starkey	IGNITE I30 ITC	FDA UDI	Class II	Active
Audigy	AGXSZ I90 BTE 13	FDA UDI	Class II	Active
Starkey	HALO 2 I1000 RIC 312R	FDA UDI	Class II	Active
Nuear	NOW IQ PRO WRLS BTE 13 PWRPLS	FDA UDI	Class II	Active
Starkey	STARLINK 2.0 CHARGER CUSTOM 002	FDA UDI	Class II	Active
Microtech	MICROTECH PORTRAIT 2000 ITC	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 16 RIC RT	FDA UDI	Class II	Active
Audigy	AGXS3S I20 HALF SHELL	FDA UDI	Class II	Active
Starkey	3 Series 30 BTE Power Plus 13	FDA UDI	Class I	Active
Audibel	AUDIBEL DAVINCI I1200 ITE	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS SIGNATURE SERIES 20 CIC NW	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 2400 MRIC 312	FDA UDI	Class II	Active
Starkey	HALO IQ I1600 RIC 312R	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA AI 2400 MRIC 312	FDA UDI	Class II	Active
Audibel	START 1200 BTE 312	FDA UDI	Class II	Active
Audibel	START 8 WRLS RIC 312	FDA UDI	Class II	Active
All American	PRIDE I2400 HALF SHELL	FDA UDI	Class II	Active
Starkey	3 Series30 CIC	FDA UDI	Class I	Active
Audiosync	AUDIOSYNC VIA 1600 ITC R	FDA UDI	Class II	Active
Microtech	SUMMIT I2400 CIC	FDA UDI	Class II	Active
Starkey	MUSE IQ 1200 ITC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 1600 RIC R	FDA UDI	Class II	Active
Nuear	NOW PRO ITE	FDA UDI	Class I	Active
Audiosync	AUDIOSYNC INTRIGUE AI 12 MRIC R	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC EDGE AI 16 CIC	FDA UDI	Class II	Active
Amplifon	PORTABLE CHARGER R-S GE\|FULLPOWER UNBRANDED FR-DE-NL	FDA UDI	Class II	Active
Audigy	AGXSM 1600 MRIC 312	FDA UDI	Class I	Active
Microtech	MICROTECH ESENTIA 1600 ITE R	FDA UDI	Class II	Active
Starkey	MUSE IQ I1000 BTE 13	FDA UDI	Class II	Active
Starkey	MUSE 1600 RIC 312t	FDA UDI	Class II	Active
Audigy	AGXSM IQ I1600 CIC	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 1600 HS R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 1000 RIC 312	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI 24 CIC 312	FDA UDI	Class II	Active
Audibel	A4 PLATINUM CIC	FDA UDI	Class II	Active
Nuear	NOW Pro BTE 13	FDA UDI	Class I	Active
Audibel	START IQ 1000I WRLS RIC 312R	FDA UDI	Class II	Active
Starkey	MUSE IQ I1600 RIC R	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 WRLS BTE 13	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 1600 MRIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC EDGE AI 24 HS R	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA AI 2000 RIC 312	FDA UDI	Class II	Active
Microtech	KINNECT IQ I2400 RIC 13	FDA UDI	Class II	Active
Audigy	AGXS3S I20 BTE 312	FDA UDI	Class II	Active
Audiosync	AudioSync Axio i4 BTE 13d	FDA UDI	Class II	Active
Nuear	INTRO 1200I WRLS RIC 312	FDA UDI	Class II	Active
Audigy	AGXSM I1000 CIC	FDA UDI	Class II	Active
Audibel	A2 PLATINUM WRLS ITE	FDA UDI	Class II	Active

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Authorised Representatives

Starkey Laboratories (Germany) GmbH DE

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