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Acc. Pro Link Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8 927 0100 000Model PROGRAMMING
by Wsaud A/S
Identity
- Trade Name
- ACC. PRO LINK KIT EUDAMEDWidex FDA UDI
- Generic Name
- Hearing aid wireless-fitting computer-aided set FDA UDI
- Device Name
- PRO LINK FDA UDI
- Model / Reference
- PROGRAMMING EUDAMED8 927 0100 000 EUDAMEDPRO LINK FDA UDI
- Description
- PRO LINK FDA UDI
Identifiers
- Catalog Number
- 8 927 0100 000 FDA UDI
- Primary DI / UDI-DI
- 05706069664287 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-80-45-4U EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid wireless-fitting computer-aided set 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
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
Yes
FDA UDI
Acc. Pro Link Kit 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-80-45-4U | 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 a367da26-c80f-4899-bc95-d90c7cadfda8 61 fields · synced Jun 19, 2026
- FDA UDI 677ecadd-49a9-477a-9cbc-43ade8366a46 36 fields · synced May 30, 2026