Starkey Evolv Ai 1000 Bte 13 Pwrpls
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- STARKEY EVOLV AI 1000 BTE 13 PWRPLS EUDAMEDSTARKEY EVOLV AI 1000 BTE 13 EUDAMEDSTARKEY FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- BTE Air Conduction Hearing Aid EUDAMEDEvolv AI EUDAMED
- Model / Reference
- Evolv AI EUDAMED63248 EUDAMEDBehind-the-Ear (BTE) EUDAMED63267-1 EUDAMEDSTARKEY EVOLV AI 1000 BTE 13 FDA UDISTARKEY EVOLV AI 1000 POWER PLUS BTE 13 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842318187420 EUDAMEDFDA UDI00842318184283 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
- Air-conduction hearing aid, behind-the-ear 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-ear
Starkey Evolv Ai 1000 Bte 13 Pwrpls by Starkey Laboratories Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Amplifon — Sonova AG · Class II
- Phonak Naída L30-SP — Sonova AG · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- HHM — Oticon A/S · Class II
- Signia — WS Audiology USA, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0842318163241UT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (4)
- EUDAMED ad4e30cd-9643-42d3-9dfc-7ea7e5348697 61 fields · synced Jul 20, 2026
- FDA UDI fca6b4f6-6f74-403d-813f-21a769f6bc4a 33 fields · synced May 29, 2026
- FDA UDI 24d18fab-7b8e-4423-99e1-027f51d25eef 33 fields · synced May 29, 2026
- EUDAMED 09e6fdd6-0b92-42f0-af42-df53236cb10b 61 fields · synced Jul 20, 2026