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App Widex Remote Care Android
EUDAMEDFDA UDIClass I (EU MDR)
Ref 21035228Model PROGRAMMING
by Wsaud A/S
Identity
- Trade Name
- APP WIDEX REMOTE CARE ANDROID EUDAMEDWIDEX FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- APP WIDEX REMOTE CARE ANDROID FDA UDI
- Model / Reference
- PROGRAMMING EUDAMED21035228 EUDAMEDRemote Care 1.3.4 FDA UDI
- Description
- APP WIDEX REMOTE CARE ANDROID FDA UDI
Identifiers
- Catalog Number
- 21035228 FDA UDI
- Primary DI / UDI-DI
- 05706069779714 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-79-45-7J EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
FDA UDI
App Widex Remote Care Android by Wsaud A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5714880-WSA-79-45-7J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED aafc4365-4d58-43e6-8a6f-62c43a7bd023 61 fields · synced Jul 8, 2026
- FDA UDI 4e5b7811-ff3a-4cc9-85fb-21e851e9a18c 35 fields · synced May 29, 2026