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Myoelectric Hand System with Three fingers for Wrist Disarticulation (One-Motio…
EUDAMEDClass I (EU MDR)
Ref FX--061SModel Myoelectric Upper Limb Prostheses
Identity
- Trade Name
- Myoelectric Hand System with Three fingers for Wrist Disarticulation (One-Motion Freedom) EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFX--061S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211669 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211669 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 with Three fingers for Wrist Disarticulation (One-Motio… 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 0bf6343b-5286-4832-a3dc-8daa0da31988 61 fields · synced Oct 6, 2026