Identity
- Trade Name
- STARKEY EVOLV AI 1600 ITC R EUDAMEDSTARKEY FDA UDI
- Generic Name
- Tinnitus masking application software FDA UDI
- Device Name
- Evolv AI EUDAMED
- Model / Reference
- Custom EUDAMED63308-SHT EUDAMEDSTARKEY EVOLV AI 1600 ITC R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842318185853 EUDAMEDFDA UDI
- Basic UDI-DI
- 0842318163311UP EUDAMED
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- EMDN Code
- Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) 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, canalTinnitus masking application software
Starkey by Starkey Laboratories Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Tinnitus masking application software.
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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 1958af85-197e-4d42-8dc1-c6d4f5ab4957 33 fields · synced Jun 19, 2026
- EUDAMED 4ed1cb4f-5bbf-44fe-a948-3ee444dde7aa 61 fields · synced Jun 19, 2026