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Helix
EUDAMEDClass IIa (EU MDR)
Ref 143-02370192Model ITEKIT Hearing Aids Series
Identity
- Trade Name
- Helix EUDAMED
- Device Name
- ITEKIT Family EUDAMED
- Model / Reference
- ITEKIT Hearing Aids Series EUDAMED143-02370192 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549130909 EUDAMED
- Basic UDI-DI
- B-08682549130909 EUDAMED
- EMDN Code
- Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) 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
Helix by Ear Technic Hearing Aids — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08682549130909 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ear Technic Hearing Aids
- EUDAMED SRN
- TR-MF-000034630
Sources (1)
- EUDAMED 9668de9f-cd53-4bf7-93ca-7741aa6f3085 61 fields · synced Jun 19, 2026