Identity
- Trade Name
- STARKEY EVOLV AI 2400 IIC NW EUDAMEDSTARKEY FDA UDI
- Generic Name
- Tinnitus masking application software FDA UDI
- Device Name
- Evolv AI EUDAMED
- Model / Reference
- Custom EUDAMED63327-SHT EUDAMEDSTARKEY EVOLV AI 2400 IIC NW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842318187147 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318163311UP EUDAMED
- FDA Product Code
- ESD FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMED
- GMDN Term
- Tinnitus masking application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, canalTinnitus masking application software
Starkey by Starkey Laboratories Inc. — Class I — 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
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
Sources (2)
- FDA UDI cf970666-c1e4-4333-810a-1fef2f7e0e91 33 fields · synced Sep 30, 2026
- EUDAMED 03f7628c-b820-4862-bb16-3246bed5ea9f 61 fields · synced Jun 18, 2026