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Agilik

by Bionic Power Inc. Canada EUDAMED

Ref AGILIK - LEFTModel AGILIK

EMDN Y06121202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number754016250AGILIK47 Basic UDI-DIDate13 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
AGILIK, AGILIK - LEFT
Primary DI / UDI-DI
07540162500015
Basic UDI-DI
754016250AGILIK47
EMDN Code
Y06121202 Energy return orthoses for knee-ankle-foot
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CA-MF-000039465
Authorised representative
Bionic Power Italy S.r.l. IT-AR-000037093

Other devices from Bionic Power Inc.

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 67652ddf-776b-489f-bda4-542b73acf9c9 61 fields · synced 22 Oct 2026