Identity
- Trade Name
- Leon R Versus EUDAMED
- Device Name
- Leon EUDAMED
- Model / Reference
- Leon EUDAMED110400001206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873859573 EUDAMED
- Basic UDI-DI
- 471987385LeonXZ EUDAMED
- Direct Marketing DI
- 04719873859573 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Leon R Versus by Karma Medical Products Co., Ltd. — 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 | 471987385LeonXZ | Class I | Active |
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Manufacturer
- Manufacturer
- Karma Medical Products Co., Ltd
- EUDAMED SRN
- TW-MF-000013206
- Authorised Representative
- KARMA MOBILITY S.L. ES-AR-000004852
Sources (1)
- EUDAMED edc549f5-159f-4f81-b13b-f7fdda10e14c 61 fields · synced Oct 7, 2026