Identity
- Trade Name
- KM-2000 EUDAMED
- Device Name
- KM-2000 EUDAMED
- Model / Reference
- KM-2500 EUDAMED110404000026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873856992 EUDAMED
- Basic UDI-DI
- 471987385KM-2000FB EUDAMED
- Direct Marketing DI
- 04719873856992 EUDAMED
- EMDN Code
- Y122103,Y122106 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
Km-2000 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 | 471987385KM-2000FB | 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 fb5eb5cd-85f5-4b52-8d56-16f97e60d430 61 fields · synced Oct 8, 2026