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Myoelectric Hand System of Carbon Fiber with Three Fingers for Wrist Disarticul…
EUDAMEDClass I (EU MDR)
Ref FX--071SModel Myoelectric Upper Limb ProsthesesRef FX--077S
Identity
- Trade Name
- Myoelectric Hand System of Carbon Fiber with Three Fingers for Wrist Disarticulation EUDAMEDMyoelectric Hand System of Carbon Fiber with Three Fingers for Elbow Disarticulation (Two-Motion Freedom) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFX--071S EUDAMEDFX--077S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211744 EUDAMED06978867211799 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211744 EUDAMED06978867211799 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
Myoelectric Hand System of Carbon Fiber with Three Fingers for Wrist Disarticul… 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 (2)
- EUDAMED 29f151ee-38ab-476f-8043-03b4a8e2a317 61 fields · synced Oct 6, 2026
- EUDAMED fc3a53e8-bb36-4207-b937-323cda5d841c 61 fields · synced May 19, 2026