Is this your brand? Sign in to claim ownership.
Sign in to claim this brandStarkey 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
- —
- —
- [email protected]
- Phone
- +1 800 328 8602
- PRRC Contact
- Brian Dahl
- EUDAMED SRN
- US-MF-000014382
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (5591)
Page 10 of 112| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Audigy | Audigy AGXs G Series AI 16 RIC 312 | FDA UDI | Class II | Active |
| Audiosync | AUDIOSYNC ARC AI 1200 CIC | FDA UDI | Class II | Active |
| Starkey | STARKEY EVOLV AI BTE 13 | FDA UDI | Class II | Active |
| Kind | KIND KINDEVO 3430 RIC 312 | FDA UDI | Class II | Active |
| Audigy | AUDIGY AGXSPI I1200 ITC | FDA UDI | Class II | Active |
| Microtech | MICROTECH ENVY AI 1600 HS R | FDA UDI | Class II | Active |
| Starkey | 3 SERIES I90 BTE 13 | FDA UDI | Class II | Active |
| Audibel | AUDIBEL VIA 2400 BTE 13 | FDA UDI | Class II | Active |
| Microtech | SUMMIT IQ I1600 ITE | FDA UDI | Class II | Active |
| Starkey | Muse 1600 BTE 13 | FDA UDI | Class I | Active |
| Starkey | 3 SERIES I110 ITC | FDA UDI | Class II | Active |
| Audigy | AGXSM IQ I2400 RIC 312 | FDA UDI | Class II | Active |
| Nuear | NOW IQ PREMIER BTE 13 PWRPLS | FDA UDI | Class II | Active |
| Nuear | NOW CROS RIC 312t | FDA UDI | Class II | Active |
| Audibel | A4 IQ SILVER WRLS MRIC 312 | FDA UDI | Class II | Active |
| Audibel | A4I GOLD WRLS RIC 312 | FDA UDI | Class II | Active |
| All American | PRIDE 1200 CIC | FDA UDI | Class II | Active |
| Kind | KINDviano CROS RIC R | FDA UDI | Class II | Active |
| Audigy | AUDIGY AGXSLIV AI 2000 RIC 312 | FDA UDI | Class II | Active |
| Nuear | INTRO 6 WRLS ITE | FDA UDI | Class II | Active |
| Audibel | A4 IQ SILVER WRLS BTE 13 | FDA UDI | Class II | Active |
| Microtech | THRIVE W10 ITC | FDA UDI | Class II | Active |
| Audibel | A4 GOLD HALF SHELL | FDA UDI | Class II | Active |
| Audibel | A4 IQ PLATINUM WRLS CIC | FDA UDI | Class II | Active |
| Audiosync | AUDIOSYNC ARC AI 2000 POWER PLUS BTE 13 | FDA UDI | Class II | Active |
| Microtech | MICROTECH ESENTIA AI 1000 BTE R | FDA UDI | Class II | Active |
| Miracle-Ear | MEMINI E 5 7S R-RT | FDA UDI | Class II | Active |
| Kind | KIND KINDEVO 2230R BTE R | FDA UDI | Class II | Active |
| Microtech | SUMMIT IQ I1200 MRIC 312R | FDA UDI | Class II | Active |
| Starkey | STARKEY EVOLV AI BTE R | FDA UDI | Class II | Active |
| Microtech | MICROTECH ESENTIA 1000 MRIC 312 | FDA UDI | Class II | Active |
| Starkey | Axio 16 BTE 13d | FDA UDI | Class I | Active |
| Microtech | MICROTECH ESENTIA AI 1600 ITC R | FDA UDI | Class II | Active |
| Audibel | AUDIBEL VIA AI 2000 ITE R | FDA UDI | Class II | Active |
| Audibel | A4 CROSBICROS BTE 13 | FDA UDI | Class II | Active |
| Starkey | Z SERIES I110 BTE 13 | FDA UDI | Class II | Active |
| Audibel | (DEMO) AUDIBEL ARC AI 2400 RIC R | FDA UDI | Class II | Active |
| Starkey | STARKEY LIVIO 2400 MRIC 312 | FDA UDI | Class II | Active |
| Kind | KIND KINDVITALO 5400R RIC R | FDA UDI | Class II | Active |
| Audibel | AUDIBEL VIA 2000 ITC R | FDA UDI | Class II | Active |
| Nuear | NOW PREMIER MRIC 312 | FDA UDI | Class I | Active |
| Audiosync | AudioSync Axio i16 BTE 13d | FDA UDI | Class II | Active |
| Nuear | NOW IQ PREMIER WRLS BTE 13 | FDA UDI | Class II | Active |
| Nuear | INTRO 4 WRLS ITE | FDA UDI | Class II | Active |
| Starkey | 3 SERIES I30 ITE | FDA UDI | Class II | Active |
| Audigy | AGXSZ I90 HALF SHELL | FDA UDI | Class II | Active |
| Nuear | INTRO 4 WRLS BTE 13 | FDA UDI | Class II | Active |
| Audibel | AUDIBEL VITALITY AI RIC 312 | FDA UDI | Class II | Active |
| Microtech | SUMMIT 1200 ITC | FDA UDI | Class I | Active |
| Audibel | INVISIBEL SYNERGY PLATINUM WRLS IIC | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.