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by Becker Orthopedic Appliance Company United States EUDAMED

Ref U-18LSModel 351 EMDN Y060624

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number194545Custom5F Basic UDI-DIDate5 Mar 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Full Contact AFO Custom
Model / Reference
351, U-18LS
Primary DI / UDI-DI
00194545103637
Basic UDI-DI
194545Custom5F
EMDN Code
Y060624 Shoulder-elbow orthoses
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000004002
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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 6485f597-e67d-473f-8338-090d6b084b67 61 fields · synced 22 Oct 2026