Skip to content

Assy, Lever, HD, Right

by Becker Orthopedic Appliance Company United States EUDAMED

Ref MX003HD7RModel MX Series

EMDN Y06121202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number194545MXGU Basic UDI-DIDate21 Jan 2022RegisteredStatusActive

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
Lever Release System
Model / Reference
MX Series, MX003HD7R
Primary DI / UDI-DI
00194545098391
Basic UDI-DI
194545MXGU
EMDN Code
Y06121202 Energy return orthoses for knee-ankle-foot
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000004002
Authorised representative
Acorn Regulatory Consultancy Services Ltd IE-AR-000000592

Other devices from Becker Orthopedic Appliance Company

See all devices from Becker Orthopedic Appliance Company →

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 cc2ecaa0-46c6-4e06-ba29-d6461528a1ba 61 fields · synced 22 Oct 2026