Identity
- Trade Name
- KM-7000 EUDAMED
- Device Name
- KM-7000 EUDAMED
- Model / Reference
- KM-7501 EUDAMED110400000378 EUDAMED110404000005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873857043 EUDAMED04719873857036 EUDAMED
- Basic UDI-DI
- 471987385KM-7000GE 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-7000 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-7000GE | 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 (2)
- EUDAMED c7eb5722-8c8e-4c17-bb46-9592eac803ad 61 fields · synced Oct 6, 2026
- EUDAMED 07ebbd2a-6635-4162-9a16-b6b6e528053b 61 fields · synced May 18, 2026