Identity

Trade Name
ΕΠΙΣΤΡΑΓΑΛΙΔΑ Neo ONE SIZE EUDAMED
Device Name
ΕΠΙΣΤΡΑΓΑΛΙΔΑ Neo ONE SIZE / ANKLE SUPPORT NEOPRENE ONE SIZE EUDAMED
Model / Reference
0557 EUDAMED

Identifiers

Primary DI / UDI-DI
05204914380615 EUDAMED
Basic UDI-DI
52049140557LH EUDAMED
EMDN Code
Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece 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

Category: Ankle/foot orthosis

ΕΠΙΣΤΡΑΓΑΛΙΔΑ Neo ONE SIZE by Ανατομικ Χελπ Ανωνυμη Εταιρια Εμποριας Και Κατασκευης Ορθοπεδικων Ειδων Α.ε. — 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
GR-MF-000015975

Sources (1)

  • EUDAMED b4832997-cdc6-467a-905b-c65a6099c292 61 fields · synced Jul 9, 2026