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Lunaris IO

by Axiles Bionics BV Belgium EUDAMED

Ref LUNC2SXXZModel Lunaris IO EMDN Y062409

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54040365PD00001TC Basic UDI-DIDate9 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Lunaris IO, LUNC2SXXZ
Primary DI / UDI-DI
05404036500117
Basic UDI-DI
54040365PD00001TC
EMDN Code
Y062409 Transtibial prostheses (for amputation under knee)
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000025722

Related devices

Category: Mechanical-resistance external ankle-foot prosthesis

Other devices from Axiles Bionics BV

See all devices from Axiles Bionics BV →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED a5d595b4-4599-4479-96ae-0f1cdc7d1730 61 fields · synced 24 Oct 2026