Helix

by Ear Technic Hearing Aids 162 variants

Ref 140-024801121Model BTE Hearing Aids Series

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-08683873084302 Basic UDI-DI	Date8 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: BTE Family
Model / Reference: BTE Hearing Aids Series, 140-024801121

Primary DI / UDI-DI: 08683873084302, 08683873082926, 08683873082940, 08683873082964, 08683873085064, 08683873082919
Basic UDI-DI: B-08683873084302, B-08683873082926, B-08683873082940, B-08683873082964, B-08683873085064, B-08683873082919
EMDN Code: Y2145060101, Y2145060102

Device Class: Class IIa
EU market of registration: Türkiye

Manufacturer details

EUDAMED SRN: TR-MF-000034630

Other devices from Ear Technic Hearing Aids

Earnet

Class IIa
Anaton

Class IIa
Helix

Class IIa
Earnet

Class IIa
Earnet

Class IIa
Anaton

Class IIa

See all devices from Ear Technic Hearing Aids →

Properties

Other properties (11)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No