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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 4 of 112

Device	Model / Reference	Registries	Class	Status
Audiosync	AUDIOSYNC INTRIGUE AI 16 RIC 312	FDA UDI	Class II	Active
Starkey	Axio 4 BTE 312d	FDA UDI	Class I	Active
Audibel	AUDIBEL VIA 1000 BTE R	FDA UDI	Class II	Active
Audibel	AUDIBEL DAVINCI I1600 ITE	FDA UDI	Class II	Active
Starkey	HALO IQ I1000 RIC 312R	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 1600 BTE 13	FDA UDI	Class II	Active
Microtech	PROPEL W40 BTE 13	FDA UDI	Class II	Active
Starkey	(DEMO) STARKEY EVOLV AI 2400 RIC R	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 1000 ITE R	FDA UDI	Class II	Active
Nuear	SDS PRO WRLS ITC	FDA UDI	Class II	Active
Nuear	ISDS PREMIER WRLS BTE 13	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 1000 ITC R	FDA UDI	Class II	Active
Microtech	THRIVE W30 ITE	FDA UDI	Class II	Active
Audigy	AGXS3S I110 ITC	FDA UDI	Class II	Active
Audibel	START 8 WRLS ITE	FDA UDI	Class II	Active
Audigy	AGXS3S I30 ITC	FDA UDI	Class II	Active
Starkey Hearing Technologies	STARKEY HEARING TECHNOLOGIES REMOTE	FDA UDI	Class II	Active
Starkey	MUSE 2400 BTE 13 PWRPLS	FDA UDI	Class II	Active
Audibel	AUDIBEL DAVINCI 1000 ITE	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA 1600 RIC R	FDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 1200 BTE 13	FDA UDI	Class II	Active
Pro Akustik	PRO AKUSTIK IPRO T.5 AI BTE 13	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 1000 RIC R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSPI 1000 IIC	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 2000 BTE 13	FDA UDI	Class II	Active
Starkey	MUSE I2400 BTE 13 PWRPLS	FDA UDI	Class II	Active
Amplifon	CUSTOM CHARGER I GE\|FULLPOWER UNBRANDED ST	FDA UDI	Class II	Active
Microtech	MICROLENS SYN IQ I2000 IIC	FDA UDI	Class II	Active
Amplifon	AMPLIFON AMPLI-ENERGY R 5\|6S R ST (TIER DEMO)	FDA UDI	Class II	Active
Kind	KIND KINDVEVO 5430 MRIC 312	FDA UDI	Class II	Active
Microtech	THRIVE W20 HALF SHELL	FDA UDI	Class II	Active
Audigy	AGXSP I90 RIC 13	FDA UDI	Class II	Active
Nuear	INTRO 1200 RIC 312t	FDA UDI	Class I	Active
Microtech	PROPEL W30 CIC	FDA UDI	Class II	Active
Audigy	AGXsm 1600 BTE 13	FDA UDI	Class I	Active
Audiosync	AudioSync Axio 12 BTE 312d	FDA UDI	Class I	Active
Nuear	NUEAR CIRCA 2400 BTE 13	FDA UDI	Class II	Active
Audigy	AGXSZ I90 BTE 312	FDA UDI	Class II	Active
Audibel	A3 GOLD WRLS HALF SHELL	FDA UDI	Class II	Active
Miracle-Ear	Miracle-EarMINI 4 CIC 10 BL	FDA UDI	Class II	Active
Starkey	EVOLV AI ITC R	FDA UDI	Class II	Active
Nuear	NuEar NE Series AI 16 RIC 312	FDA UDI	Class II	Active
Audibel	A4 IQ GOLD CIC	FDA UDI	Class II	Active
Audibel	START 1200 WRLS BTE 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA 2400 BTE R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1200 ITE R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 1200 ITE R	FDA UDI	Class II	Active
Amplifon	AMPLIFON AMPLI-ENERGY B 5 TH R-P	FDA UDI	Class II	Active
Starkey	3 Series 70 BTE 13	FDA UDI	Class I	Active
Microtech	SUMMIT IQ I1600 MRIC 312R	FDA UDI	Class II	Active

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