Helix
by Ear Technic Hearing Aids 162 variants
Ref 142-02350171Model ITE Hearing Aids Series
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08682549131623 | Date1 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Device Name
- ITE Family
- Model / Reference
- ITE Hearing Aids Series, 142-02350171
- Primary DI / UDI-DI
- 08682549131623, 08682549131616
- Basic UDI-DI
- B-08682549131623, B-08682549131616
- EMDN Code
- Y21450603 Box hearing aids
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000034630
Other 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