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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 3 of 112

Device	Model / Reference	Registries	Class	Status
Microtech	KINNECT 2 I2000 RIC 312R	FDA UDI	Class II	Active
Audiosync	DEBUT 165W ITC	FDA UDI	Class II	Active
Starkey	Axio i6 BTE 312d	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 WRLS MRIC 312	FDA UDI	Class II	Active
Audigy	AGXSZ I110 ITC	FDA UDI	Class II	Active
Audigy	AGXS3S I70 ITE	FDA UDI	Class II	Active
Audibel	START 9 WRLS RIC 312	FDA UDI	Class II	Active
Starkey	MUSE I1200 RIC 312t	FDA UDI	Class II	Active
Microtech	PROPEL W20 BTE 312	FDA UDI	Class II	Active
Starkey	Starkey Legacy Premium Custom Charger	FDA UDI	Class II	Active
Nuear	SDS PREMIER WRLS HALF SHELL	FDA UDI	Class II	Active
Starkey	3 SERIES I30 BTE 13	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 20 ITE R	FDA UDI	Class II	Active
Starkey	STARKEY PICASSO 1600 CIC	FDA UDI	Class II	Active
Audigy	AGXSM I1600 ITE	FDA UDI	Class II	Active
Nuear	NOW PREMIER WRLS ITE	FDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 2000 CIC NW	FDA UDI	Class II	Active
Miracle-Ear	MIRACLE-EAR MEENERGY 2 HS R 6S\|ST	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1600 RIC R	FDA UDI	Class II	Active
Audibel	A4I IQ PLATINUM WRLS RIC 13	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EVOLV AI 1600 RIC 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1600 RIC 312	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA AI 1600 BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY SIGNATURE SERIES 24 IIC NW	FDA UDI	Class I	Active
Starkey	STARKEY PICASSO 2400 HALF SHELL	FDA UDI	Class II	Active
Audibel	START IQ 1200I WRLS RIC 312	FDA UDI	Class II	Active
All American	PRIDE 2400 BTE 312	FDA UDI	Class II	Active
Audibel	START 1200 MRIC 312	FDA UDI	Class II	Active
Microtech	SUMMIT 2000 CIC	FDA UDI	Class II	Active
Pro Akustik	PRO AKUSTIK IPRO 11.6 AI BTE R	FDA UDI	Class II	Active
Microtech	MICROTECH MT NXG AI 24 MRIC R (DEMO)	FDA UDI	Class II	Active
Audibel	AUDIBEL INTRIGUE AI DEMO RIC 312	FDA UDI	Class II	Active
Miracle Ear	MEMINI E 2 7S R-312	FDA UDI	Class II	Active
Starkey	3 SERIES I70 CIC	FDA UDI	Class II	Active
Nuear	NOW IQ PRESTIGE WRLS ITE	FDA UDI	Class II	Active
Starkey	EVOLV AI MRIC 312 (GS)	FDA UDI	Class II	Active
Starkey	Starkey Legacy Custom Charger	FDA UDI	Class II	Active
Starkey	EVOLV AI BTE R (GS)	FDA UDI	Class II	Active
Starkey	3 SERIES I110 BTE 13	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC ARC AI 1000 POWER PLUS BTE 13	FDA UDI	Class II	Active
Starkey	Z SERIES I90 BTE 13	FDA UDI	Class II	Active
Starkey	HALO 2 I1000 RIC 13	FDA UDI	Class II	Active
Starkey	Z SERIES I30 ITC	FDA UDI	Class II	Active
Miracle-Ear	MIRACLE-EAR BLISS 5 RIC RT	FDA UDI	Class II	Active
Miracle-Ear	MIRACLE EAR MEENERGY 5 ITE R	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 2000 HS R	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA 2400 RIC 312	FDA UDI	Class II	Active
Starkey	STARKEY EVOLV AI CROS BTE 13	EUDAMEDFDA UDI	Class II	Active
Audibel	AUDIBEL VIA 2400 MRIC 312	FDA UDI	Class II	Active
Nuear	NUEAR EDGE AI 24 MRIC R (TIER DEMO)	FDA UDI	Class II	Active

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