← Back to catalogue
Ha Ejy E-Fm E05 E50 Atbg
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10989850Model BTE
by Widex A/S
Identity
- Trade Name
- HA EJY E-FM E05 E50 ATBG EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- HA EJY E-FM E05 E50 ATBG FDA UDI
- Model / Reference
- BTE EUDAMED10989850 EUDAMEDENJOY E-FM 50 FDA UDI
- Description
- HA EJY E-FM E05 E50 ATBG FDA UDI
Identifiers
- Catalog Number
- 10989850 FDA UDI
- Primary DI / UDI-DI
- 05706069789447 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05706069789447 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW 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 UDI874.3400 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
No
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
Ha Ejy E-Fm E05 E50 Atbg 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-05706069789447 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Widex A/S
- EUDAMED SRN
- DK-MF-000025153
Sources (2)
- EUDAMED c3d09181-52db-488a-8876-968ad601da9d 61 fields · synced Jul 18, 2026
- FDA UDI f08ad28e-dc6b-458b-b4b8-26560505f508 35 fields · synced May 30, 2026