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Forearm Myoelectric Hand System of Carbon Fiber with Three Fingers (Thumb Two- …
EUDAMEDClass I (EU MDR)
Ref FX--072SRModel Myoelectric Upper Limb Prostheses
Identity
- Trade Name
- Forearm Myoelectric Hand System of Carbon Fiber with Three Fingers (Thumb Two- Dimension) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFX--072SR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211768 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211768 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 Myoelectric Hand System of Carbon Fiber with Three Fingers (Thumb Two- … 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 7184ad3a-6584-4e2f-9649-ec014f49c845 61 fields · synced Oct 9, 2026