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ΑΡΘΡΩΣΗ ΠΟΔΟΚΝΗΜΙΚΗΣ ΑΝΟΞΕΙΔΩΤΗ STEP-ON 100 / MEDIAL RIGHT/LATERAL LEFT /extension

by Μ.birli - a.tsitouras O.E.

Ref Step-On H100MR/LL Ext., Step-On Ankle Hinge 100 MR/LL Ext./basicModel Step-On H100ML/LR Ext.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5200413201796L5 Basic UDI-DI Date17 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
ΑΡΘΡΩΣΗ ΠΟΔΟΚΝΗΜΙΚΗΣ ΑΝΟΞΕΙΔΩΤΗ STEP-ON 100 / MEDIAL RIGHT/LATERAL LEFT /extension
Αρθρωση Ποδοκνημικης Ανοξειδωτη Step-on 100 / Medial Right / Lateral Left
Device Name
Ankle Hinge Joint
Model / Reference
Step-On H100ML/LR Ext., Step-On H100MR/LL Ext., Step-On Ankle Hinge 100 MR/LL Ext./basic
Primary DI / UDI-DI
05200413201802, 05200413201680
Basic UDI-DI
5200413201796L5
Direct Marketing DI
05200413201680
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000013450

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No