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Fpfp Ejy E-Cic Tr R E100 Dbrn2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10987981Model CUSTOM
by Widex A/S
Identity
- Trade Name
- FPFP EJY E-CIC TR R E100 DBRN2 EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- FPFP EJY E-CIC TR R E100 DBRN2 FDA UDI
- Model / Reference
- CUSTOM EUDAMED10987981 EUDAMEDENJOY E-CIC 100 FDA UDI
- Description
- FPFP EJY E-CIC TR R E100 DBRN2 FDA UDI
Identifiers
- Catalog Number
- 10987981 FDA UDI
- Primary DI / UDI-DI
- 05706069791860 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05706069791860 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-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
Fpfp Ejy E-Cic Tr R E100 Dbrn2 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-05706069791860 | 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 430bde4b-b3c1-45db-8bbc-71dfec8050e3 61 fields · synced Jun 18, 2026
- FDA UDI 5a105fca-858f-4d22-8f98-ab0e2e1f7639 35 fields · synced May 30, 2026