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 13 of 112

Device	Model / Reference	Registries	Class	Status
Starkey	Z SERIES I110 CIC	FDA UDI	Class II	Active
Microtech	MICROTECH MT NXG AI CROSBICROS RIC 312	FDA UDI	Class II	Active
Nuear	NUEAR SAVANT AI 2400 ITE R	FDA UDI	Class II	Active
Starkey	MUSE IQ I2400 BTE 13	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 1600 ITE R	FDA UDI	Class II	Active
Starkey	MUSE IQ 1600 MRIC 312	FDA UDI	Class II	Active
Nuear	NOW IQ PRESTIGE WRLS MRIC 312	FDA UDI	Class II	Active
Audibel	A2 GOLD WRLS HALF SHELL	FDA UDI	Class II	Active
Audibel	START 7 WRLS BTE 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA 2000 ITE R	FDA UDI	Class II	Active
Starkey	STARKEY LIVIO 2400 RIC 312	FDA UDI	Class II	Active
Starkey	MUSE IQ 2000 BTE 312	FDA UDI	Class II	Active
Nuear	NOW IQ PREMIER RIC 312	FDA UDI	Class II	Active
Microtech	SUMMIT 2000 ITE	FDA UDI	Class II	Active
Nuear	Intro 1200 Wrls BTE 13	FDA UDI	Class II	Active
All American	PRIDE I1000 HALF SHELL	FDA UDI	Class II	Active
Audibel	Audibel SL 2.0 Prem Charger Custom	FDA UDI	Class II	Active
Microtech	THRIVE W20 BTE 13	FDA UDI	Class II	Active
Microtech	THRIVE W20 ITC	FDA UDI	Class II	Active
Amplifon	Amplifon Standard Charger FR-DE-NL	FDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 1200 POWER PLUS BTE 13	FDA UDI	Class II	Active
Audigy	AGXSM 2000 ITC	FDA UDI	Class II	Active
Nuear	NOW PRESTIGE WRLS BTE 312	FDA UDI	Class II	Active
Microtech	MICROTECH ENVY AI 1200 BTE R	FDA UDI	Class II	Active
Starkey	SOUNDLENS SYN IQ I1000 IIC	FDA UDI	Class II	Active
Audiosync	AudioSync A4 Platinum Wrls BTE 13	FDA UDI	Class II	Active
Nuear	SDS II PREMIER WRLS MRIC 312	FDA UDI	Class II	Active
Starkey	WI SERIES I90 HALF SHELL	FDA UDI	Class II	Active
Microtech	SUMMIT I2400 ITC	FDA UDI	Class II	Active
Kind	“KIND name” for iOS	FDA UDI	Class II	Active
Nuear	NOW IQ CROSBICROS BTE 312	FDA UDI	Class II	Active
Starkey	EVOLV AI IIC NW	FDA UDI	Class I	Active
Audiosync	AUDIOSYNC ARC AI 2400 BTE R	FDA UDI	Class II	Active
All American	PRIDE I1200 HALF SHELL	FDA UDI	Class II	Active
Audigy	AGXSM I2000 MRIC 312	FDA UDI	Class II	Active
Starkey	STARKEY PICASSO 2400 ITC	FDA UDI	Class II	Active
Audibel	Start 1000 BTE 13	FDA UDI	Class I	Active
Nuear	INTRO 4 WRLS CIC	FDA UDI	Class II	Active
Audigy	AGXSM I1600 HALF SHELL	FDA UDI	Class II	Active
Starkey	STARKEY EDGE AI CROS RIC 312	FDA UDI	Class II	Active
Microtech	KINNECT IQ I1600 RIC 13	FDA UDI	Class II	Active
Audibel	A2 SILVER WRLS ITC	FDA UDI	Class II	Active
All American Hearing	Pride 1200 BTE 13	FDA UDI	Class I	Active
Nuear	NOW PREMIER WRLS ITE	FDA UDI	Class II	Active
Microtech	PROPEL W10 BTE 13	FDA UDI	Class II	Active
Starkey	MUSE IQ CROSBICROS BTE 13	FDA UDI	Class II	Active
Audibel	A3 PLATINUM WRLS BTE 312	FDA UDI	Class II	Active
Starkey	HALO IQ I2000 RIC 312	FDA UDI	Class II	Active
Audiosync	AUDIOSYNC VIA AI 1600 RIC 312	FDA UDI	Class II	Active
Microtech	SUMMIT I1000 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.