← Back to catalogue
Ha Motion C&G Sp 5ix Rgd
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21043426Model BTE
by Wsaud A/S
Identity
- Trade Name
- HA MOTION C&G SP 5IX RGD EUDAMEDSignia FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- HA MOTION C&G SP 5IX RGD FDA UDI
- Model / Reference
- BTE EUDAMED21043426 EUDAMEDMotion C&G SP 5IX FDA UDI
- Description
- HA MOTION C&G SP 5IX RGD FDA UDI
Identifiers
- Catalog Number
- 21043426 FDA UDI
- Primary DI / UDI-DI
- 05714880274042 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-28-10-48 EUDAMED
- FDA Product Code
- OSM 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 II FDA UDI
- Regulation Number
- 874.3305 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 Motion C&G Sp 5ix Rgd 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-28-10-48 | 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 1ee8a78d-16b5-46bb-a87e-c169ffe24ef5 61 fields · synced Jul 15, 2026
- FDA UDI 306a0b5e-59f9-45e9-ae68-b81c05134ae7 35 fields · synced May 30, 2026