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Ha Evk E-Fm 30 Deblu
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8 401 0170 136Model BTE
by Widex A/S
Identity
- Trade Name
- HA EVK E-FM 30 DEBLU EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- WIDEX EVOKE E-FM (Deep Blue ) 30, RC coil FDA UDI
- Model / Reference
- BTE EUDAMED8 401 0170 136 EUDAMEDE-FM FDA UDI
- Description
- WIDEX EVOKE E-FM (Deep Blue ) 30, RC coil FDA UDI
Identifiers
- Catalog Number
- 8 401 0170 136 FDA UDI
- Primary DI / UDI-DI
- 05706069787788 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05706069787788 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear 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
Ha Evk E-Fm 30 Deblu 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-05706069787788 | 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 9fae9506-a861-43fc-908f-90fa0cc727b2 61 fields · synced Jun 19, 2026
- FDA UDI ea882043-d780-410f-bbdc-34e32edeccbd 35 fields · synced May 30, 2026