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Static Wrist Hand Orthosis, Kit, Small, Left

by Becker Orthopedic Appliance Company EUDAMED

Active European Union

Ref U-16-SK-LModel 351

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  • Withdrawn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

Device Name
Full Contact AFO Custom
Model / Reference
351, U-16-SK-L
Primary DI / UDI-DI
00194545103415
Market of Registration
Germany

Manufacturer details

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

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