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Agilik Connect

by Bionic Power Inc. Canada EUDAMED

Ref BP08891Model Agilik Connect

EMDN Y061280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number754016250AgilikConnect5W 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 24 Oct 2026

Model / Reference
Agilik Connect, BP08891
Primary DI / UDI-DI
07540162500589
Basic UDI-DI
754016250AgilikConnect5W
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 c0e7564b-52fc-41b0-a66f-517260554fb5 61 fields · synced 24 Oct 2026