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Above Elbow Myoelectric Hand System with Three Fingers (Two-Motion Freedom)
EUDAMEDClass I (EU MDR)
Ref FX--067SModel Myoelectric Upper Limb Prostheses
Identity
- Trade Name
- Above Elbow Myoelectric Hand System with Three Fingers (Two-Motion Freedom) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFX--067S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211737 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211737 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
Above Elbow Myoelectric Hand System with Three Fingers (Two-Motion Freedom) by Medi Global Assistive Device Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697886721MU000SS | 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 e05da298-27fc-42bd-8131-0acec1744af7 61 fields · synced Jul 16, 2026