Is this your brand? Sign in to claim ownership.

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 18 of 112

Device	Model / Reference	Registries	Class	Status
Nuear	NOW PRESTIGE WRLS MRIC 312	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2400 MRIC 312	FDA UDI	Class II	Active
Starkey	MUSE IQ 1200 RIC 312	FDA UDI	Class II	Active
Audibel	START IQ 1200 WRLS ITC	FDA UDI	Class II	Active
Nuear	NOW IQ PREMIER WRLS HALF SHELL	FDA UDI	Class II	Active
Audigy Group	AGXSM IQ 1600 CIC	FDA UDI	Class II	Active
Nuear	NOW IQ PRESTIGE WRLS ITC	FDA UDI	Class II	Active
Microtech	PROPEL W30 HALF SHELL	FDA UDI	Class II	Active
Microtech	PROPEL W50 ITC	FDA UDI	Class II	Active
Nuear	NuEar 2.0 Prem Charger RIC RT	FDA UDI	Class II	Active
Starkey	Axio 16 PL BTE 312d	FDA UDI	Class I	Active
Nuear	NOW IQ 1000 WRLS BTE 13	FDA UDI	Class II	Active
Audigy	AGXSP 2 I1200 RIC 312R	FDA UDI	Class II	Active
Microtech	SUMMIT I1600 CIC	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 2000 HS R	FDA UDI	Class II	Active
Microtech	MICROLENS SYN IQ 1200 IIC	FDA UDI	Class II	Active
Starkey	MUSE I2400 CIC	FDA UDI	Class II	Active
Audibel	AUDIBEL SL 2.0 PREM CHARGER RIC RT 002	FDA UDI	Class II	Active
Starkey	Soundlens 2 70	FDA UDI	Class I	Active
Starkey	3 SERIES I20 BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY PICASSO 1000 ITC	FDA UDI	Class II	Active
Audibel	INVISIBEL SYNERGY PLATINUM IIC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA AI 2000 ITC R	FDA UDI	Class II	Active
Audibel	START IQ 1000 MRIC 312R	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA EDGE AI 2400 ITE R	FDA UDI	Class II	Active
Starkey	3 Series 70 RIC 312	FDA UDI	Class I	Active
Microtech	SUMMIT 2000 BTE 312	FDA UDI	Class II	Active
Starkey	STARKEY EVOLV AI 1600 MRIC 312	EUDAMEDFDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 1600 POWER PLUS BTE 13	FDA UDI	Class II	Active
Starkey	3 SERIES I30 RIC 312	FDA UDI	Class II	Active
Nuear	SDS PRO WRLS RIC 312	FDA UDI	Class II	Active
Audibel	INVISIBEL SYNERGY GOLD IIC	FDA UDI	Class II	Active
Nuear	MINISCOPIC SYN IQ PRO IIC	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EDGE AI 20 HS R	FDA UDI	Class II	Active
Microtech	Summit i1000 BTE 13	FDA UDI	Class II	Active
Starkey	MUSE IQ I2400 RIC 312	FDA UDI	Class II	Active
Starkey	MUSE CROSBICROS BTE 312	FDA UDI	Class II	Active
Nuear	INTRO 1000 WRLS BTE 13 PWRPLS	FDA UDI	Class II	Active
Microtech	SUMMIT IQ 1600 MRIC 312R	FDA UDI	Class II	Active
Starkey	STARKEY GENESIS AI CROS RIC RT (GS)	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS GENESIS AI 24 MRIC R	FDA UDI	Class II	Active
Audibel	AUDIBEL ARC AI 2400 HS R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 1200 HS R	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA 2000 BTE R	FDA UDI	Class II	Active
Starkey Hearing Technologies	STARKEY HEARING TECHNOLOGIES TABLE MICROPHONE	FDA UDI	Class II	Active
Kind	KIND KINDEVO 2230 BTE 13	FDA UDI	Class II	Active
Microtech	Summit 1000 BTE 13	FDA UDI	Class I	Active
Microtech	SUMMIT I1000 HALF SHELL	FDA UDI	Class II	Active
Nuear	SDS PRESTIGE WRLS MRIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA 1000 MRIC 312	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Starkey Laboratories (Germany) GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.