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Audibel A Series AI 12 P BTE 13
EUDAMEDClass IIa (EU MDR)
Ref 63423-2Model Behind-the-Ear (BTE)
Identity
- Trade Name
- Audibel A Series AI 12 P BTE 13 EUDAMED
- Device Name
- G Series AI EUDAMED
- Model / Reference
- Behind-the-Ear (BTE) EUDAMED63423-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840388212431 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
Category: Air-conduction hearing aid, behind-the-ear
Audibel A Series AI 12 P BTE 13 by Starkey Laboratories Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
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- Miracle-Ear — WS Audiology USA, Inc. · Class II
- HHM — Oticon A/S · Class II
- Signia — WS Audiology USA, Inc. · Class II
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 bf492c6e-8428-4118-ac73-ed7b2d84a042 61 fields · synced Jun 19, 2026