Identity
- Trade Name
- C_ITE VIO E214 ITE EUDAMED
- Model / Reference
- CUSTOM EUDAMED10964068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056839099742 EUDAMED
- Basic UDI-DI
- B-04056839099742 EUDAMED
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
C_ite Vio E214 Ite by Sivantos GmbH — 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-04056839099742 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (1)
- EUDAMED 8452bf95-a899-477a-90c5-400de79a1907 61 fields · synced Jul 14, 2026