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Forearm Cosmetic Hand System with Adaptor
EUDAMEDClass I (EU MDR)
Ref FX--081LModel Body-powered Upper Limb Prostheses
Identity
- Trade Name
- Forearm Cosmetic Hand System with Adaptor EUDAMED
- Model / Reference
- Body-powered Upper Limb Prostheses EUDAMEDFX--081L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867211386 EUDAMED
- Basic UDI-DI
- 697886721BU000NZ EUDAMED
- Direct Marketing DI
- 06978867211386 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 Cosmetic Hand System with Adaptor by Medi Global Assistive Device Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697886721BU000NZ | 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 26d34e0d-142a-412c-81ed-eded1296aa02 61 fields · synced Jul 9, 2026