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 7 of 112

Device	Model / Reference	Registries	Class	Status
Audibel	A4 IQ GOLD WRLS BTE 13	FDA UDI	Class II	Active
Nuear	LOOK PREMIER HALF SHELL	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC EDGE AI MRIC R	FDA UDI	Class II	Active
Starkey	MUSE IQ I1000 MRIC 312R	FDA UDI	Class II	Active
Microtech	PROPEL W30 ITC	FDA UDI	Class II	Active
Starkey	Z SERIES I90 BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY SL 2.0 CHARGER CUSTOM 001	FDA UDI	Class II	Active
Audibel	Axio 12 BTE 312d	FDA UDI	Class I	Active
Starkey	STARLINK CHARGER (MRIC R)	FDA UDI	Class II	Active
Microtech	MICROTECH PORTRAIT I1200 CIC	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO CROSBICROS RIC R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2400 BTE 13	FDA UDI	Class II	Active
Starkey	Starkey Omega AI 24 ITE R (GS)	FDA UDI	Class II	Active
Starkey	STARKEY EVOLV AI 1000 POWER PLUS BTE 13 (PL)	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2400 ITC R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO AI 2000 RIC 312	FDA UDI	Class II	Active
Kind	KIND KINDEVO 3430R RIC R	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC EDGE AI 24 MRIC R	FDA UDI	Class II	Active
Miracle-Ear	MEMINI 5 CIC 10 BL\|ST	FDA UDI	Class I	Active
Audibel	AUDIBEL DAVINCI I1000 CIC	FDA UDI	Class II	Active
Microtech	MICROLENS SYNERGY 2400 IIC	FDA UDI	Class II	Active
Pro Akustik	PRO AKUSTIK IPRO 9.5 AI MRIC 312 (Right)	FDA UDI	Class II	Active
Miracle-Ear	MIRACLE EAR MEMINI 5 CIC 312	FDA UDI	Class II	Active
Audigy	AUDIGY AGXS EVOLV AI 1600 ITE R	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA RIC R	FDA UDI	Class II	Active
Nuear	NUEAR CANVAS 2400 IIC	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 2000 CIC	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA CROSBICROS BTE 13	FDA UDI	Class II	Active
Audibel	START IQ 1000 WRLS CIC	FDA UDI	Class II	Active
Audibel	Audibel Aris AI RIC 312	FDA UDI	Class II	Active
Miracle-Ear	MIRACLE EAR MEMINI 2 CIC 312	FDA UDI	Class II	Active
Starkey	Muse i2000 PL BTE 13	FDA UDI	Class II	Active
Starkey	STARKEY EVOLV AI 2400 ITE R	EUDAMEDFDA UDI	Class II	Active
Microtech	KINNECT 2 I1600 RIC 312R	FDA UDI	Class II	Active
Audiosync	AudioSync Axio i12 BTE 312d	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 1000 ITC R	FDA UDI	Class II	Active
Starkey	HALO IQ I2400 RIC 312R	FDA UDI	Class II	Active
Audibel	A4 GOLD BTE 13 PWRPLS	FDA UDI	Class II	Active
Starkey	3 SERIES I30 RIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA 2000 HS R	FDA UDI	Class II	Active
Starkey	Axio 8 BTE 13d	FDA UDI	Class I	Active
Nuear	ISDS PRESTIGE WRLS RIC 13	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC ARC AI 1000 RIC 312	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 1200 ITC R	FDA UDI	Class II	Active
Nuear	NUEAR CIRCA 1600 RIC 312	FDA UDI	Class II	Active
Amplifon	AMPLI-TV 2.0 LE ST	FDA UDI	Class II	Active
Starkey	STARKEY SL 2.0 CHARGER MRIC 002	FDA UDI	Class II	Active
Starkey	MUSE IQ I2000 CIC	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA 1000 BTE 13	FDA UDI	Class II	Active
Audibel	A4 PLATINUM WRLS HALF SHELL	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.