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Forearm Cosmetic Hand System
EUDAMEDClass I (EU MDR)
Ref FX--081Model Body-powered Upper Limb Prostheses
Identity
- Trade Name
- Forearm Cosmetic Hand System EUDAMED
- Model / Reference
- Body-powered Upper Limb Prostheses EUDAMEDFX--081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211379 EUDAMED
- Basic UDI-DI
- 697886721BU000NZ EUDAMED
- Direct Marketing DI
- 06978867211379 EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Forearm Cosmetic Hand System by Medi Global Assistive Device 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 | 697886721BU000NZ | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 95a2eba5-b9a1-4d82-a88b-150747a67597 61 fields · synced Jul 13, 2026