← Back to catalogue
Ha M-Core B-Li-P 80 Dkc
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10995567Model BTE
by Wsaud A/S
Identity
- Trade Name
- HA M-CORE B-LI-P 80 DKC EUDAMEDRexton FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- M-CORE B-LI-P 80 Dark Champagne FDA UDI
- Model / Reference
- BTE EUDAMED10995567 EUDAMEDM-CORE B-LI-P 80 FDA UDI
- Description
- M-CORE B-LI-P 80 Dark Champagne FDA UDI
Identifiers
- Catalog Number
- 10995567 FDA UDI
- Primary DI / UDI-DI
- 05714880108323 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-25-10-37 EUDAMED
- FDA Product Code
- ESD FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI874.3400 FDA UDI
- 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
Ha M-Core B-Li-P 80 Dkc 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-25-10-37 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 9e2f2a1a-0ea3-445c-b414-af39bc2c234e 61 fields · synced Jul 27, 2026
- FDA UDI b1838ee0-6ed5-4ec7-8f62-1e32cee91c23 35 fields · synced May 29, 2026