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Worksoft

EUDAMED

Class I (EU MDR)

Ref WO11XModel WORKSOFT

by Orthosoft

Identity

Trade Name
WORKSOFT EUDAMED
Device Name
WORKSOFT EUDAMED
Model / Reference
WORKSOFT EUDAMED
WO11X EUDAMED

Identifiers

Primary DI / UDI-DI
03760270340042 EUDAMED
Basic UDI-DI
3760270343401077465D EUDAMED
EMDN Code
Y060609 WRIST (FOREARM) ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France 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

Worksoft by Orthosoft — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Orthosoft
EUDAMED SRN
FR-MF-000000216

Sources (1)

  • EUDAMED da519a52-58aa-4a62-9e8f-2d464611119e 61 fields · synced Jun 19, 2026