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Software Comp Gps 4.7 Usb Package
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21038004Model SOFTWARE
by Wsaud A/S
Identity
- Trade Name
- SOFTWARE COMP GPS 4.7 USB PACKAGE EUDAMEDWIDEX FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- SOFTWARE COMP GPS 4.7 USB PACKAGE FDA UDI
- Model / Reference
- SOFTWARE EUDAMED21038004 EUDAMEDCompass GPS 4.7 FDA UDI
- Description
- SOFTWARE COMP GPS 4.7 USB PACKAGE FDA UDI
Identifiers
- Catalog Number
- 21038004 FDA UDI
- Primary DI / UDI-DI
- 05714880239140 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-81-42-4W EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Audiometric/hearing device software 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
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
Software Comp Gps 4.7 Usb Package 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-81-42-4W | 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 75f1b35e-4752-4f3c-b801-d220c62064f6 61 fields · synced Jul 14, 2026
- FDA UDI 3fb772a2-02ad-42df-a11a-4cbe25afa722 35 fields · synced May 30, 2026