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NuEar NE Series AI 10 P BTE 13
EUDAMEDClass IIa (EU MDR)
Ref 63424-4Model Behind-the-Ear (BTE)
Identity
- Trade Name
- NuEar NE Series AI 10 P BTE 13 EUDAMED
- Device Name
- G Series AI EUDAMED
- Model / Reference
- Behind-the-Ear (BTE) EUDAMED63424-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840388212523 EUDAMED
- Basic UDI-DI
- 0842318163400UP EUDAMED
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
NuEar NE Series AI 10 P BTE 13 by Starkey Laboratories Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0842318163400UP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (1)
- EUDAMED e821984e-b7c3-407a-9e43-420a16834f48 61 fields · synced Jul 28, 2026