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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 2 of 112

Device	Model / Reference	Registries	Class	Status
Audigy	AUDIGY AGXSLIV 1000 ITE R	FDA UDI	Class II	Active
Audigy	AGXSP IQ I1000 RIC 312	FDA UDI	Class II	Active
Audigy	AGXSM IQ I2000 BTE 13 PWRPLS	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 RIC 312	FDA UDI	Class II	Active
Audigy	AGXS3S TINNITUS 30 RIC 10	FDA UDI	Class I	Active
All American	PRIDE 1000 MRIC 312	FDA UDI	Class I	Active
Starkey	WI SERIES I70 CIC	FDA UDI	Class II	Active
Nuear	INTRO 6 WRLS MRIC 312	FDA UDI	Class II	Active
Nuear	SDS PRESTIGE WRLS RIC 312	FDA UDI	Class II	Active
All American	PRIDE I2000 HALF SHELL	FDA UDI	Class II	Active
Soundgear	SOUNDGEAR AMP IIC NW	FDA UDI	Class I	Active
Microtech	MICROTECH ENVY AI 2400 BTE R	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 2400 HS R	FDA UDI	Class II	Active
Audigy	AUDIGY AGXSLIV AI 1000 HS R	FDA UDI	Class II	Active
Starkey	MUSE IQ I2400 MRIC 312R	FDA UDI	Class II	Active
Microtech	SUMMIT IQ 1200 BTE 13 PWRPLS	FDA UDI	Class II	Active
Starkey	Z SERIES I70 ITE	FDA UDI	Class II	Active
All American	PRIDE I1600 MRIC 312	FDA UDI	Class II	Active
Nuear	INTRO 4 WRLS ITC	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI 24 IIC NW	FDA UDI	Class II	Active
Starkey	MUSE 1000 CIC	FDA UDI	Class I	Active
Audibel	Audibel SL 2.0 Prem Charger Custom	FDA UDI	Class II	Active
Nuear	NOW IQ 1200 MRIC 312R	FDA UDI	Class II	Active
Starkey	Z SERIES I30 MRIC 312	FDA UDI	Class II	Active
Audibel	A2 PLATINUM WRLS BTE 312	FDA UDI	Class II	Active
Microtech	SUMMIT IQ I1600 BTE 312	FDA UDI	Class II	Active
Audiosync	AudioSync Axio i6 BTE 13d	FDA UDI	Class II	Active
Audiosync	AudioSync A4 Platinum BTE 13	FDA UDI	Class I	Active
Starkey	MUSE 2400 BTE 312	FDA UDI	Class II	Active
Microtech	KINNECT IQ I2000 RIC 13	FDA UDI	Class II	Active
Starkey	Muse 1200 PL BTE 13	FDA UDI	Class I	Active
Starkey	3 SERIES I90 RIC 312	FDA UDI	Class II	Active
Audigy	AGXSSL SYN IQ 1600 IIC	FDA UDI	Class II	Active
Starkey	STARKEY EVOLV AI 1200 CIC NW	EUDAMEDFDA UDI	Class I	Active
Starkey	STARKEY LIVIO 1200 RIC 312	FDA UDI	Class II	Active
Audiosync	AudioSync Axio i8 BTE 312d	FDA UDI	Class II	Active
Microtech	KINNECT W40 BTE 13	FDA UDI	Class II	Active
Starkey	3 SERIES I110 ITC	FDA UDI	Class II	Active
Audibel	AUDIBEL MODEL A 2 RIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 1200 MRIC 312	FDA UDI	Class II	Active
Starkey	HALO 2 I1200 RIC 312R	FDA UDI	Class II	Active
Audigy	AGXSP IQ I1200 RIC 312R	FDA UDI	Class II	Active
Starkey	MUSE 1600 RIC 312t	FDA UDI	Class I	Active
Nuear	NOW IQ PREMIER ITE	FDA UDI	Class II	Active
Nuear	NOW IQ PRO MRIC 312R	FDA UDI	Class II	Active
Audibel	A2 GOLD WRLS ITC	FDA UDI	Class II	Active
Nuear	NOW IQ 1000 RIC 312	FDA UDI	Class II	Active
Amplifon	PORTABLE CHARGER R GE\|FULLPOWER UNBRANDED FR-DE-NL	FDA UDI	Class II	Active
Nuear	NUEAR CANVAS 1600 IIC	FDA UDI	Class II	Active
Audibel	A4 IQ PLATINUM WRLS BTE 13 PWRPLS	FDA UDI	Class II	Active

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