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Fpfp Evk E-Cic-M Cbrn
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8 406 0500 028Model CUSTOM
by Widex A/S
Identity
- Trade Name
- FPFP EVK E-CIC-M CBRN EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- Widex EVOKE E-CIC-M (Clay brown ) FDA UDI
- Model / Reference
- CUSTOM EUDAMED8 406 0500 028 EUDAMEDE-CIC-M FDA UDI
- Description
- Widex EVOKE E-CIC-M (Clay brown ) FDA UDI
Identifiers
- Catalog Number
- 8 406 0500 028 FDA UDI
- Primary DI / UDI-DI
- 05706069662559 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05706069662559 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) 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
Yes
FDA UDI
Fpfp Evk E-Cic-M Cbrn by Widex A/S — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05706069662559 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Widex A/S
- EUDAMED SRN
- DK-MF-000025153
Sources (2)
- EUDAMED ee61dbd7-3365-499b-915e-a6a10bfc59ff 61 fields · synced Jul 15, 2026
- FDA UDI 2d8c0801-81f6-4e4d-a1c3-4f804778bdfd 35 fields · synced May 30, 2026