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by Össur Iceland ehf. Iceland EUDAMED

Ref NPD1-0008Model BU00116

EMDN Y061803

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5690967BU00116ND Basic UDI-DIDate27 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

Model / Reference
BU00116, NPD1-0008
Primary DI / UDI-DI
05690977835061
Basic UDI-DI
5690967BU00116ND
EMDN Code
Y061803 Partial hand prostheses (including fingers prostheses)
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IS-MF-000000173

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 71a8929b-a726-4b6a-9ea0-25532d1fd91e 61 fields · synced 22 Oct 2026