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App Fit2go
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21023158Model SOFTWARE
by Wsaud A/S
Identity
- Trade Name
- APP FIT2GO EUDAMEDCONNEXX FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- APP CONNEXX FIT2GO FDA UDI
- Model / Reference
- SOFTWARE EUDAMED21023158 EUDAMEDConnexx Fit2Go FDA UDI
- Description
- APP CONNEXX FIT2GO FDA UDI
Identifiers
- Catalog Number
- 21023158 FDA UDI
- Primary DI / UDI-DI
- 05714880187229 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-79-42-79 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
App Fit2go 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-79-42-79 | 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 8217ff20-fcef-440f-a2c4-039deaf62f80 61 fields · synced Jul 23, 2026
- FDA UDI 4b1bf3c9-ee6d-46aa-aa8c-6506cdbe6784 35 fields · synced May 30, 2026