← Back to catalogue
Widex
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8 410 0142 119Model RIC
by Widex A/S
Identity
- Trade Name
- HA MOMENT MRB0 440 DEM SLVGR EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- WIDEX MOMENT MRB0 DEMO (Silver Grey ) 440, RIC 10 FDA UDI
- Model / Reference
- RIC EUDAMED8 410 0142 119 EUDAMEDMRB0 FDA UDI
- Description
- WIDEX MOMENT MRB0 DEMO (Silver Grey ) 440, RIC 10 FDA UDI
Identifiers
- Catalog Number
- 8 410 0142 119 FDA UDI
- Primary DI / UDI-DI
- 05706069908176 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-65-15-5A 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
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
No
FDA UDI
Category: Air-conduction hearing aid, receiver-in-canal
Widex by Widex A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-canal.
- SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
- AGXO — Sbo Hearing A/S · Class IIa
- SoniTon UP6 312 trial — Sonova AG · Class IIa
- HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
- HANSATON — Hansaton Akustik GmbH · Class II
- PHONAK — Sonova AG · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Widex A/S
Sources (2)
- FDA UDI 25f4c0fc-172b-4b15-b7d7-ae481b2e0c31 35 fields · synced Jul 9, 2026
- EUDAMED 367e1ae9-4eff-4a21-b18a-5973b191a334 61 fields · synced Jul 9, 2026