Starkey
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- STARKEY EVOLV AI 1600 BTE R EUDAMEDSTARKEY FDA UDI
- Generic Name
- Tinnitus masking application software FDA UDI
- Device Name
- Evolv AI EUDAMED
- Model / Reference
- Behind-the-Ear (BTE) EUDAMED63272-1 EUDAMEDSTARKEY EVOLV AI 1600 BTE R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842318185433 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318163241UT EUDAMED
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Tinnitus masking application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, behind-the-earTinnitus masking application software
Starkey by Starkey Laboratories Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tinnitus masking application software.
- NUEAR — Starkey Laboratories Inc. · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- AUDIGY — Starkey Laboratories Inc. · Class II
- AUDIOSYNC — Starkey Laboratories Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
Sources (2)
- FDA UDI 41a8b1fd-764e-41e6-aec4-6d5fbc448078 33 fields · synced Jul 18, 2026
- EUDAMED 8d282733-634b-4725-b0d6-b742b8887621 61 fields · synced Jul 18, 2026