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Ergo Nimble (KP-10.3S)
EUDAMEDClass I (EU MDR)
Ref 110404050018Model Ergo Nimble
Identity
- Trade Name
- Ergo Nimble (KP-10.3S) EUDAMED
- Device Name
- KP-10.3S EUDAMED
- Model / Reference
- Ergo Nimble EUDAMED110404050018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873856619 EUDAMED
- Basic UDI-DI
- 471987385KP-1L8 EUDAMED
- Direct Marketing DI
- 04719873856619 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
Ergo Nimble (KP-10.3S) 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 | 471987385KP-1L8 | 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 c9b34a1a-4704-474b-ba11-0b35e6f1bdea 61 fields · synced Oct 6, 2026