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Above Elbow Myoelectric Hand System (Three-Motion Freedom)
EUDAMEDClass I (EU MDR)
Ref MAEH-3Model Myoelectric Upper Limb Prostheses
Identity
- Trade Name
- Above Elbow Myoelectric Hand System (Three-Motion Freedom) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDMAEH-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211812 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211812 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 (Three-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 57a5bd81-fc4c-4b6a-baf1-c8b899362045 61 fields · synced Jun 18, 2026