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Elbow Contracture Orthosis – Left – S

EUDAMED

Class I (EU MDR)

Ref ML-0311-4

by Beyazgrup Sağlik Ürünleri̇ İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Identity

Trade Name
Elbow Contracture Orthosis – Left – S EUDAMED
Device Name
İSTİRAHAT MOLDU(P.A.F.O) - SMALL EUDAMED
Model / Reference
ML-0311-4 EUDAMED

Identifiers

Primary DI / UDI-DI
08680702012253 EUDAMED
Basic UDI-DI
86807020ORTEZVK EUDAMED
EMDN Code
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Category: Ankle/foot orthosis

Elbow Contracture Orthosis – Left – S by Beyazgrup Sağlik Ürünleri̇ İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class I — MDR — listed in EUDAMED

Similar devices

Also classified as Ankle/foot orthosis.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
TR-MF-000031770

Sources (1)

  • EUDAMED f9815ce8-de82-440c-9f79-53f0bff89bd4 61 fields · synced Sep 30, 2026