Ha Evk E-F2 440 Deblu
EUDAMEDFDA UDIClass IIa (EU MDR)
by Widex A/S
Identity
- Trade Name
- HA EVK E-F2 440 DEBLU EUDAMEDHA EVK E-F2 USA 440 DEBLU EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- Widex EVOKE E-F2 (Deep Blue ) 440, Telecoil, RC coil FDA UDI
- Model / Reference
- RIC EUDAMED10973358 EUDAMED8 403 0341 136 EUDAMEDE-F2 FDA UDI
- Description
- Widex EVOKE E-F2 (Deep Blue ) 440, Telecoil, RC coil FDA UDI
Identifiers
- Catalog Number
- 8 403 0341 136 FDA UDI
- Primary DI / UDI-DI
- 05706069711479 EUDAMED05706069803341 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05706069711479 EUDAMEDB-05706069803341 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, receiver-in-canal
Ha Evk E-F2 440 Deblu by Widex A/S — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05706069711479 | 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 (3)
- EUDAMED 6d32f36c-6508-40a7-98ab-fc898dd0e515 61 fields · synced Jul 19, 2026
- EUDAMED b7f8a225-42fa-4ee6-ac0e-1d99fdd75a2b 61 fields · synced May 18, 2026
- FDA UDI b4cb3671-4a5b-434b-913a-dbc6b16b2d32 35 fields · synced May 29, 2026