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App Zen Tinnitus (ios)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5 300 0006 001Model REMOTE
by Wsaud A/S
Identity
- Trade Name
- APP ZEN TINNITUS (IOS) EUDAMEDWidex FDA UDI
- Generic Name
- Tinnitus masking application software FDA UDI
- Device Name
- Tinnitus app iOS version 1.0 FDA UDI
- Model / Reference
- REMOTE EUDAMED5 300 0006 001 EUDAMEDTinnitus app FDA UDI
- Description
- Tinnitus app iOS version 1.0 FDA UDI
Identifiers
- Catalog Number
- 5 300 0006 001 FDA UDI
- Primary DI / UDI-DI
- 05706069674712 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-79-60-7D EUDAMED
- FDA Product Code
- KLW FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Tinnitus masking application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 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 Zen Tinnitus (ios) 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 4097db54-98bb-40d7-b92b-cd9bfd522373 61 fields · synced Jun 18, 2026
- FDA UDI fd184825-0846-4a4f-a3d8-2d89a426b616 35 fields · synced May 29, 2026