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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 12 of 112

Device	Model / Reference	Registries	Class	Status
Starkey	STARKEY LIVIO EDGE AI CROSBICROS RIC 312	FDA UDI	Class II	Active
Audibel	A3 PLATINUM WRLS ITC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA CROSBICROS RIC 312	FDA UDI	Class II	Active
Microtech	SILVERTONE 50WD HALF SHELL	FDA UDI	Class II	Active
Microtech	SUMMIT 1200 BTE 13 PWRPLS	FDA UDI	Class II	Active
Amplifon	AMPLIFON AMPLI-MINI I 3 TH 10 IIC NWL	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC ARC AI 2000 CIC	FDA UDI	Class II	Active
Kind	KIND KINDEVO 1230 BTE 13	FDA UDI	Class II	Active
Starkey	GS Starkey SL 2.0 Charger Custom	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EVOLV AI 1200 CIC NW	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 24 RIC RT (DEMO)	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC INTRIGUE AI 16 HS R	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 2400 POWER PLUS BTE 13	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 1000 RIC 312	FDA UDI	Class II	Active
Starkey	3 Series 110 HC	FDA UDI	Class I	Active
Starkey	STARKEY LIVIO AI RIC R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 2000 RIC 312	FDA UDI	Class II	Active
Audigy	AGXSM IQ 1000 BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY SOUNDGEAR PHANTOM ITE	FDA UDI	Class II	Active
Audigy	AGXSM 2400 CIC	FDA UDI	Class II	Active
Microtech	SUMMIT IQ I1200 CIC	FDA UDI	Class II	Active
Microtech	PROPEL W30 HALF SHELL	FDA UDI	Class II	Active
Nuear	NOW IQ PRESTIGE WRLS RIC 312	FDA UDI	Class II	Active
Nuear	NUEAR NE NXG AI RIC RT	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 2000 BTE 13	FDA UDI	Class II	Active
Nuear	SDS II PRESTIGE WRLS RIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC EDGE AI 24 RIC RT	FDA UDI	Class II	Active
Amplifon	AMPLIFON AMPLI-CONNECT B 3 TH 13-SP	FDA UDI	Class II	Active
Audibel	A4 IQ SILVER MRIC 312R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 1600 ITE R	FDA UDI	Class II	Active
Audiosync	A3I SILVER RIC 13	FDA UDI	Class II	Active
Audigy	AGXSSL SYN IQ I2000 IIC	FDA UDI	Class II	Active
Nuear	INTRO 1200 WRLS MRIC 312	FDA UDI	Class II	Active
Starkey	HALO I70 BTE 13	FDA UDI	Class II	Active
Audibel	AUDIBEL VITALITY AI 24 RIC RT (TIER DEMO)	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 2000 BTE R	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 1000 RIC R	FDA UDI	Class II	Active
Audigy	AGXSP 2 I2000 RIC 312	FDA UDI	Class II	Active
Starkey	StarLink Edge Table Microphone	FDA UDI	Class II	Active
Audigy	Audigy AGXs G Series AI 16 RIC R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV 1000 RIC R	FDA UDI	Class II	Active
Miracle-Ear	MEPOWER I 3 ITC R	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 2400 ITE R	FDA UDI	Class II	Active
Starkey	STARKEY PICASSO I1000 CIC	FDA UDI	Class II	Active
Microtech	SUMMIT I2400 RIC 312t	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 1600 IIC NW	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI 16 RIC RT	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA EDGE AI 2400 BTE 13	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 BTE 13 PWRPLS	FDA UDI	Class II	Active
Nuear	SDS PRO WRLS ITC	FDA UDI	Class II	Active

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Starkey Laboratories (Germany) GmbH DE

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