Identity
- Trade Name
- Flexx Tall EUDAMED
- Device Name
- KM-8000 EUDAMED
- Model / Reference
- KM-8000Ⅲ EUDAMED110404000086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873857111 EUDAMED
- Basic UDI-DI
- 471987385KM-8000GM EUDAMED
- Direct Marketing DI
- 04719873857111 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
Flexx Tall 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-8000GM | 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 a935a424-7eb7-474b-a994-b226211fbc66 61 fields · synced Oct 6, 2026