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App Signia V2.3+
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10996563Model REMOTE
by Wsaud A/S
Identity
- Trade Name
- APP SIGNIA V2.3+ EUDAMEDSignia FDA UDI
- Generic Name
- Hearing aid/implant system remote control FDA UDI
- Device Name
- APP SIGNIA FDA UDI
- Model / Reference
- REMOTE EUDAMED10996563 EUDAMEDSignia App FDA UDI
- Description
- APP SIGNIA FDA UDI
Identifiers
- Catalog Number
- 10996563 FDA UDI
- Primary DI / UDI-DI
- 05714880113167 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-79-60-7D 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 IIa 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
Yes
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
App Signia V2.3+ by Wsaud A/S — Class IIa — 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-79-60-7D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 18076811-5931-4336-b747-e46c750f507d 61 fields · synced Jul 19, 2026
- FDA UDI 0f85325a-1975-46d0-ad83-1075597f5009 35 fields · synced May 30, 2026