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Agilik Care

by Bionic Power Inc. Canada EUDAMED

Ref BP08632Model Agilik Care

EMDN Y061280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number754016250AgilikCare2D Basic UDI-DIDate1 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Agilik Care
Model / Reference
Agilik Care, BP08632
Primary DI / UDI-DI
07540162500572
Basic UDI-DI
754016250AgilikCare2D
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
Special Device Type
Software
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 b017be94-6c22-4ff7-b9ee-940cb45bcfda 61 fields · synced 22 Oct 2026