Identity
- Trade Name
- Kudu EUDAMED
- Model / Reference
- Seating EUDAMED951xxxxxxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707292940254 EUDAMED
- Basic UDI-DI
- 5707292122200ZJ EUDAMED
- EMDN Code
- Y122199 WHEELCHAIRS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Kudu by R82 A/S — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151492 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5707292122200ZJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R82 A/S
- EUDAMED SRN
- DK-MF-000000772
Sources (2)
- EUDAMED d3cafb2f-4340-4531-a4c7-dcd7cd25b37d 61 fields · synced Jun 19, 2026
- FDA 510(k) K151492 1 fields · synced May 18, 2026