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Forearm Myoelectric Hand System with Three Fingers (Built-in Battery)
EUDAMEDClass I (EU MDR)
Ref FX--062SCModel Myoelectric Upper Limb ProsthesesRef FX--062S
Identity
- Trade Name
- Forearm Myoelectric Hand System with Three Fingers (Built-in Battery) EUDAMEDForearm Myoelectric Hand System with Three Fingers EUDAMED
- Model / Reference
- Myoelectric Upper Limb Prostheses EUDAMEDFX--062SC EUDAMEDFX--062S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211683 EUDAMED06978867211676 EUDAMED
- Basic UDI-DI
- 697886721MU000SS EUDAMED
- Direct Marketing DI
- 06978867211683 EUDAMED06978867211676 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 with Three Fingers (Built-in Battery) 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 ee92a9ab-6a6b-4905-83f5-5505740196f5 61 fields · synced Jul 23, 2026
- EUDAMED c95a98f6-2b5c-456d-bf43-a7e72add1b09 61 fields · synced May 17, 2026