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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 15 of 112

Device	Model / Reference	Registries	Class	Status
Audibel	INVISIBEL SYNERGY PLATINUM IIC	FDA UDI	Class II	Active
Starkey	MUSE 2000 CIC	FDA UDI	Class I	Active
Audigy	AGXSZ I110 BTE 13	FDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 1200 CIC NW	FDA UDI	Class II	Active
Microtech	PROPEL W10 BTE 13	FDA UDI	Class II	Active
Audibel	A4 IQ PLATINUM WRLS RIC 312	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI BTE R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO EDGE AI CROSBICROS BTE 13	FDA UDI	Class II	Active
Starkey	Muse i2000 mRIC 312t	FDA UDI	Class II	Active
Starkey	MUSE IQ 1000 CIC	FDA UDI	Class II	Active
Audibel	INVISIBEL SYN IQ 1200 IIC	FDA UDI	Class II	Active
Nuear	SDS PREMIER WRLS BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY MODEL S 3 RIC 312	FDA UDI	Class II	Active
Nuear	INTRO 1000 CIC	FDA UDI	Class I	Active
Audiosync	AUDIOSYNC EDGE AI 20 CIC	FDA UDI	Class II	Active
Nuear	NuEar Noble AI RIC 312	FDA UDI	Class II	Active
Nuear	NOW PRO RIC 312t	FDA UDI	Class II	Active
Microtech	SILVERTONE 50WD ITC	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 1000 RIC 312	FDA UDI	Class II	Active
Audigy	AGXSM I1000 HALF SHELL	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 2000 ITC R	FDA UDI	Class II	Active
Audibel	AUDIBEL DAVINCI I1600 ITC	FDA UDI	Class II	Active
Nuear	NOW PREMIER WRLS BTE 312	FDA UDI	Class II	Active
Nuear	NOW PRESTIGE WRLS RIC 312t	FDA UDI	Class II	Active
Starkey	STARKEY EDGE AI 24 RIC 312 (TIER DEMO)	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 2400 RIC 312	FDA UDI	Class II	Active
Starkey	3 Series 30 RIC 312	FDA UDI	Class I	Active
Starkey	STARKEY PICASSO I1200 IIC	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA 2400 RIC R	FDA UDI	Class II	Active
Starkey	MUSE I1200 BTE 13 PWRPLS	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA AI 1600 ITE R	FDA UDI	Class II	Active
Audiosync	DEBUT 85W CIC	FDA UDI	Class II	Active
Starkey	MUSE I2400 ITC	FDA UDI	Class II	Active
Audibel	A4 IQ SILVER WRLS HALF SHELL	FDA UDI	Class II	Active
Audigy	AGXSP 2 I1600 RIC 312	FDA UDI	Class II	Active
Nuear	SDS PRESTIGE WRLS CIC	FDA UDI	Class II	Active
Starkey	Z SERIES I110 HALF SHELL	FDA UDI	Class II	Active
Paradigm	SurfLink Remote Microphone 2	FDA UDI	Class II	Active
Starkey	Z SERIES I90 ITC	FDA UDI	Class II	Active
Audibel	AUDIBEL DAVINCI I2000 ITE	FDA UDI	Class II	Active
Microtech	SILVERTONE 30WD ITE	FDA UDI	Class II	Active
Starkey	STARKEY EDGE AI 24 RIC RT (DEMO)	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA EDGE AI 2400 BTE R	FDA UDI	Class II	Active
Miracle-Ear	MEMINI E 4 7S R-RT	FDA UDI	Class II	Active
Kind	KIND KINDVITALO 2200R BTE R	FDA UDI	Class II	Active
Nuear	NUEAR CANVAS I1200 ITC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 2000 RIC R	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA AI 2400 MRIC 312	FDA UDI	Class II	Active
Microtech	SUMMIT 2000 BTE 13 PWRPLS	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 WRLS BTE 312	FDA UDI	Class II	Active

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Starkey Laboratories (Germany) GmbH DE

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