Identity
- Trade Name
- RGK Elite X EUDAMED
- Device Name
- Sports Wheelchair RGK EUDAMED
- Model / Reference
- Elite X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050063059657 EUDAMED
- Basic UDI-DI
- 4050063mwcsport5J EUDAMED
- Direct Marketing DI
- 04050063059657 EUDAMED
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
RGK Elite X by Sunrise Medical GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4050063mwcsport5J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunrise Medical GmbH
- EUDAMED SRN
- DE-MF-000006320
Sources (1)
- EUDAMED fca2a818-376f-4045-814f-89d557e78156 61 fields · synced Jun 19, 2026