Identity
- Trade Name
- Helix EUDAMED
- Device Name
- BTE Family EUDAMED
- Model / Reference
- BTE Hearing Aids Series EUDAMED138-024601120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683873084951 EUDAMED08683873084937 EUDAMED
- Basic UDI-DI
- B-08683873084951 EUDAMEDB-08683873084937 EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) 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, receiver-in-canal
Helix by Ear Technic Hearing Aids — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-canal.
- SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
- HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
- AGXO — Sbo Hearing A/S · Class IIa
- SoniTon UP6 312 trial — Sonova AG · Class IIa
- HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
- HANSATON — Hansaton Akustik GmbH · Class II
- PHONAK — Sonova AG · Class II
- AMPLIFON — Starkey Laboratories Inc. · 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-08683873084951 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ear Technic Hearing Aids
- EUDAMED SRN
- TR-MF-000034630
Sources (2)
- EUDAMED f2c3d267-c909-4e88-a15e-0c8ea0e35042 61 fields · synced Oct 7, 2026
- EUDAMED bfe2bdac-e2d1-4a3e-91d6-9ccffd2aa3f5 61 fields · synced May 17, 2026