Identity
- Trade Name
- Helix EUDAMED
- Device Name
- BTE Family EUDAMED
- Model / Reference
- BTE Hearing Aids Series EUDAMED134-02340180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549130749 EUDAMED
- Basic UDI-DI
- B-08682549130749 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
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Air-conduction hearing aid, behind-the-ear
Helix by Ear Technic Hearing Aids — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
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- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682549130749 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ear Technic Hearing Aids
- EUDAMED SRN
- TR-MF-000034630
Sources (1)
- EUDAMED 9cd898a7-0880-4bc2-8914-59dcb5351e53 61 fields · synced Jun 19, 2026