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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 9 of 112

Device	Model / Reference	Registries	Class	Status
Nuear	SDS PREMIER WRLS HALF SHELL	FDA UDI	Class II	Active
Audibel	AUDIBEL DAVINCI 1200 ITE	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 2400 HS R	FDA UDI	Class II	Active
Audibel	A4 IQ SILVER BTE 13 PWRPLS	FDA UDI	Class II	Active
Nuear	NuEar NE Series AI 10 RIC R	EUDAMEDFDA UDI	Class II	Active
Microtech	SUMMIT IQ 1600 CIC	FDA UDI	Class II	Active
Audibel	A4 IQ SILVER WRLS ITC	FDA UDI	Class II	Active
Starkey	MUSE 1600 MRIC 312	FDA UDI	Class I	Active
Starkey	3 SERIES I110 ITC	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC SIGNATURE SERIES 24 CIC R NW	FDA UDI	Class I	Active
Starkey	GS CUSTOM PREMIUM CHARGER - (1 NA PLUG)	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSPI 2400 HALF SHELL	FDA UDI	Class II	Active
Audibel	(Demo) AUDIBEL VIA MRIC 312	FDA UDI	Class II	Active
Microtech	SUMMIT I2400 ITE	FDA UDI	Class II	Active
Starkey	Z SERIES I30 CIC	FDA UDI	Class II	Active
Audigy	AGXSM 1000 HALF SHELL	FDA UDI	Class I	Active
Starkey	STARKEY LIVIO AI 2000 BTE 13	FDA UDI	Class II	Active
Audibel	A2 PLATINUM WRLS BTE 13	FDA UDI	Class II	Active
Nuear	NOW IQ PRO WRLS ITC	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA EDGE AI CROSBICROS RIC 312	FDA UDI	Class II	Active
Starkey	Starkey Omega AI 24 RIC RT (DEMO)	FDA UDI	Class II	Active
Starkey	STARKEY EDGE AI CROS RIC 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO CROSBICROS BTE 13	FDA UDI	Class II	Active
All American	PRIDE 2400 CIC	FDA UDI	Class I	Active
Starkey	STARKEY LIVIO AI 1000 RIC 312	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 1600 BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY GENESIS AI RIC 312 (GS TIER DEMO)	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI 12 MRIC R	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 2400 ITC R	FDA UDI	Class II	Active
Audibel	Audibel A Series AI 10 RIC R	EUDAMEDFDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 20 CIC	FDA UDI	Class II	Active
Microtech	SUMMIT 1000 ITC	FDA UDI	Class I	Active
Miracle-Ear	MIRACLE-EARLINK MINI REMOTE MICROPHONE	FDA UDI	Class II	Active
Audigy Group	AGXSM IQ 2400 CIC	FDA UDI	Class II	Active
Audibel	RANGE PLATINUM ITE	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA AI 1000 RIC 312	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA AI 1000 MRIC 312	FDA UDI	Class II	Active
Nuear	NOW IQ 1000 WRLS ITE	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 1600 RIC 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2400 MRIC 312	FDA UDI	Class II	Active
Audigy	AGXSM IQ 1200 BTE 13 PWRPLS	FDA UDI	Class II	Active
Microtech	SUMMIT IQ I2000 RIC 312	FDA UDI	Class II	Active
Amplifon	AMPLI-MINI E 1\|7S RITE-312	FDA UDI	Class II	Active
Audigy	AGXSZ I20 BTE 312	FDA UDI	Class II	Active
ProAkustik	“ProAkustik name” for iOS	FDA UDI	Class II	Active
Audigy	AGXSM IQ I2000 CIC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 1000 MRIC 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 1200 RIC R	FDA UDI	Class II	Active
Microtech	THRIVE W20 BTE 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2400 BTE 13	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Starkey Laboratories (Germany) GmbH DE

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