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Myoelectric Hand System of Carbon Fiber with Three Fingers for Wrist Disarticul…

EUDAMED

Class I (EU MDR)

Ref FX--071SModel Myoelectric Upper Limb ProsthesesRef FX--077S

by Medi Global Assistive Device Co., Ltd.

Identity

Trade Name
Myoelectric Hand System of Carbon Fiber with Three Fingers for Wrist Disarticulation EUDAMED
Myoelectric Hand System of Carbon Fiber with Three Fingers for Elbow Disarticulation (Two-Motion Freedom) EUDAMED
Model / Reference
Myoelectric Upper Limb Prostheses EUDAMED
FX--071S EUDAMED
FX--077S EUDAMED

Identifiers

Primary DI / UDI-DI
06978867211744 EUDAMED
06978867211799 EUDAMED
Basic UDI-DI
697886721MU000SS EUDAMED
Direct Marketing DI
06978867211744 EUDAMED
06978867211799 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 of Carbon Fiber with Three Fingers for Wrist Disarticul… 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

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Manufacturer

EUDAMED SRN
CN-MF-000034804
Authorised Representative
Humiss International B.V. NL-AR-000001490

Sources (2)

  • EUDAMED 29f151ee-38ab-476f-8043-03b4a8e2a317 61 fields · synced Oct 6, 2026
  • EUDAMED fc3a53e8-bb36-4207-b937-323cda5d841c 61 fields · synced May 19, 2026