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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 1 of 112

Device	Model / Reference	Registries	Class	Status
Audibel A Series AI 12 UP BTE 13	63433-2	EUDAMED	Class IIa	Active
NuEar NE Series AI 24 P BTE 13	63420-4	EUDAMED	Class IIa	Active
NuEar NE Series AI 10 UP BTE 13	63434-4	EUDAMED	Class IIa	Active
Ampli-Power E 5\|7s Bte-13p	63430-U	EUDAMED	Class IIa	Active
NuEar NE Series AI 10 P BTE 13	63424-4	EUDAMED	Class IIa	Active
Audibel A Series AI 16 UP BTE 13	63432-2	EUDAMED	Class IIa	Active
Starkey G Series AI 24 P BTE 13	63420-1	EUDAMED	Class IIa	Active
NuEar NE Series AI 12 P BTE 13	63423-4	EUDAMED	Class IIa	Active
Audibel A Series AI 20 P BTE 13	63421-2	EUDAMED	Class IIa	Active
OuïeZen 12 GS RIC R	63401-K	EUDAMED	Class IIa	Active
Starkey G Series AI 10 P BTE 13	63424-1	EUDAMED	Class IIa	Active
NuEar NE Series AI 16 UP BTE 13	63432-4	EUDAMED	Class IIa	Active
Starkey G Series AI 16 P BTE 13	63422-1	EUDAMED	Class IIa	Active
OuïeZen 12 GS BTE 13 UP	63433-K	EUDAMED	Class IIa	Active
Ampli-Power E 1\|7s Bte-13p	63434-U	EUDAMED	Class IIa	Active
Audibel A Series AI 24 P BTE 13	63420-2	EUDAMED	Class IIa	Active
Starkey G Series AI 20 UP BTE 13	63431-1	EUDAMED	Class IIa	Active
Ampli-Mini E 1\|7s Rite-R	63402-U	EUDAMED	Class IIa	Active
Audibel A Series AI 16 P BTE 13	63422-2	EUDAMED	Class IIa	Active
OuïeZen 12 GS RIC 312	63407-K	EUDAMED	Class IIa	Active
Ampli-Power E 2\|7s Bte-13m	63423-U	EUDAMED	Class IIa	Active
NuEar NE Series AI 24 UP BTE 13	63430-4	EUDAMED	Class IIa	Active
Ampli-Mini E 2\|7s Rite-R	63401-U	EUDAMED	Class IIa	Active
Ampli-Power E 3\|7s Bte-13p	63432-U	EUDAMED	Class IIa	Active
Ampli-Mini E 3\|7s Rite-R	63400-U	EUDAMED	Class IIa	Active
Audibel A Series AI 12 P BTE 13	63423-2	EUDAMED	Class IIa	Active
Ampli-Power E 4\|7s Bte-13m	63421-U	EUDAMED	Class IIa	Active
NuEar NE Series AI 16 P BTE 13	63422-4	EUDAMED	Class IIa	Active
Incognito GS 12 RIC R	63401-F	EUDAMED	Class IIa	Active
Incognito GS 12 BTE 13 P	63423-F	EUDAMED	Class IIa	Active
Ampli-Power E 3\|7s Bte-13m	63422-U	EUDAMED	Class IIa	Active
Audibel A Series AI 10 UP BTE 13	63434-2	EUDAMED	Class IIa	Active
Starkey G Series AI 16 UP BTE 13	63432-1	EUDAMED	Class IIa	Active
Audibel A Series AI 20 UP BTE 13	63431-2	EUDAMED	Class IIa	Active
Starkey G Series AI 20 P BTE 13	63421-1	EUDAMED	Class IIa	Active
NuEar NE Series AI 20 P BTE 13	63421-4	EUDAMED	Class IIa	Active
OuïeZen 12 GS BTE 13 P	63423-K	EUDAMED	Class IIa	Active
Starkey G Series AI 10 UP BTE 13	63434-1	EUDAMED	Class IIa	Active
Ampli-Power E 5\|7s Bte-13m	63420-U	EUDAMED	Class IIa	Active
Incognito GS 12 BTE 13 UP	63433-F	EUDAMED	Class IIa	Active
Starkey G Series AI 24 UP BTE 13	63430-1	EUDAMED	Class IIa	Active
Starkey G Series AI 12 UP BTE 13	63433-1	EUDAMED	Class IIa	Active
Nuear	INSPIRE X	FDA UDI	Class II	Active
Microtech	MICROTECH ESENTIA AI 2400 ITC R	FDA UDI	Class II	Active
Starkey	STARLINK PREMIUM MINI CHARGER (RIC RT) (1NA PLUG)	FDA UDI	Class II	Active
Audibel	AUDIBEL VIA 1000 RIC 312	FDA UDI	Class II	Active
Starkey	EVOLV AI RIC 312 (GS)	FDA UDI	Class II	Active
Audigy	AGXS3S I30 ITC	FDA UDI	Class II	Active
Starkey	MUSE IQ I1200 BTE 312	FDA UDI	Class II	Active
Starkey	MUSE IQ I1000 ITE	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Starkey Laboratories (Germany) GmbH DE

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