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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 16 of 112

Device	Model / Reference	Registries	Class	Status
Starkey	Starkey Omega AI 24 mRIC R (GS DEMO)	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 2400 BTE 13	FDA UDI	Class II	Active
Starkey	MUSE IQ I2000 HALF SHELL	FDA UDI	Class II	Active
Audiosync	AudioSync Axio 6 BTE 13d	FDA UDI	Class I	Active
Audiosync	AUDIOSYNC VIA AI 1200 RIC R	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 1000 HS R	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA 2400 HS R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSPI 2400 IIC	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV EDGE AI 2400 ITE R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1200 ITC R	FDA UDI	Class II	Active
Starkey	MUSE CROSBICROS MRIC 312	FDA UDI	Class II	Active
Audibel	START 10 WRLS BTE 312	FDA UDI	Class II	Active
Audibel	START IQ 1000 WRLS MRIC 312R	FDA UDI	Class II	Active
All American	PRIDE 1600 CIC	FDA UDI	Class II	Active
Starkey	MUSE IQ I1000 HALF SHELL	FDA UDI	Class II	Active
Starkey	Z SERIES I90 HALF SHELL	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 24 MRIC R (TIER DEMO)	FDA UDI	Class II	Active
Starkey	3 Series 70 Mini BTE 312	FDA UDI	Class I	Active
Starkey	Axio 6 PL BTE 312d	FDA UDI	Class I	Active
Nuear	INTRO 1000 RIC 312t	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 1200 RIC R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI CROS RIC RT	FDA UDI	Class II	Active
Microtech	MICROTECH PORTRAIT I2000 ITE	FDA UDI	Class II	Active
Audigy	Audigy AGXs G Series AI 16 RIC 312	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA AI 1200 BTE 13	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA CROSBICROS RIC 312	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 1000 BTE R	FDA UDI	Class II	Active
Audibel	AUDIBEL VITALITY AI 24 MRIC R (DEMO)	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 1200 RIC R	FDA UDI	Class II	Active
Audibel	AUDIBEL INTRIGUE AI MRIC R	FDA UDI	Class II	Active
Audibel	A4 IQ PLATINUM HALF SHELL	FDA UDI	Class II	Active
Microtech	SUMMIT IQ I1600 ITC	FDA UDI	Class II	Active
Starkey	Z SERIES I30 BTE 13	FDA UDI	Class II	Active
Audibel	A4 SILVER BTE 13 PWRPLS	FDA UDI	Class II	Active
Amplifon	AMPLIFON AMPLI-MINI I 5 TH 312 WL	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA 2000 HS R	FDA UDI	Class II	Active
Nuear	NuEar Noble AI RIC 312 (TIER DEMO)	FDA UDI	Class II	Active
Audibel	START IQ 1200I WRLS RIC 312R	FDA UDI	Class II	Active
Audibel	Axio i6 BTE 13d	FDA UDI	Class II	Active
Audigy	AUDIGY SIGNATURE SERIES 20 IIC NW	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1200 MRIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 1000 RIC 312	FDA UDI	Class II	Active
Starkey	MUSE IQ 2400 MRIC 312R	FDA UDI	Class II	Active
Microtech	PROPEL TINNITUS 40 RIC 10	FDA UDI	Class I	Active
Microtech	KINNECT 2 I1000 RIC 312R	FDA UDI	Class II	Active
Starkey	MUSE 1000 RIC 312t	FDA UDI	Class I	Active
Starkey	HALO 2 I2000 RIC 312R	FDA UDI	Class II	Active
Audibel	START 1200 WRLS BTE 13 PWRPLS	FDA UDI	Class II	Active
Starkey	STARKEY PICASSO I2400 IIC	FDA UDI	Class II	Active
Microtech	SILVERTONE 20WD HALF SHELL	FDA UDI	Class II	Active

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Starkey Laboratories (Germany) GmbH DE

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