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Myoelectric Arm Prostheses (Wrist Universal Rotate 360°)
EUDAMEDClass I (EU MDR)
Ref FW--001SModel Myoelectric Upper Limb Prostheses
Identity
- Trade Name
- Myoelectric Arm Prostheses (Wrist Universal Rotate 360°) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFW--001S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211713 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211713 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 Arm Prostheses (Wrist Universal Rotate 360°) 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 55d3bc95-d876-4c72-9bde-2eba6e5284a8 61 fields · synced Jun 19, 2026