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C_ite Vio E351
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21039895Model CUSTOM
by Wsaud A/S
Identity
- Trade Name
- C_ITE VIO E351 EUDAMEDViO FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- C_ITE VIO E351 FDA UDI
- Model / Reference
- CUSTOM EUDAMED21039895 EUDAMEDViO E351 FDA UDI
- Description
- C_ITE VIO E351 FDA UDI
Identifiers
- Catalog Number
- 21039895 FDA UDI
- Primary DI / UDI-DI
- 05714880249835 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-28-25-4U EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
C_ite Vio E351 by Wsaud A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5714880-WSA-28-25-4U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 7e089f30-aaaa-415e-be42-06c891ef3d6a 61 fields · synced Aug 3, 2026
- FDA UDI 150489e3-7d12-4457-bccc-65f472d65f41 35 fields · synced May 24, 2026