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Biosim Pro

by Össur Iceland ehf. Iceland EUDAMED

Ref Biosim-iOSModel BU00104

EMDN Z129082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5690967BU00104N6 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 23 Oct 2026

Model / Reference
BU00104, Biosim-iOS
Primary DI / UDI-DI
05690977836754
Basic UDI-DI
5690967BU00104N6
EMDN Code
Z129082 Various instruments for functional exploration and therapeutic interventions - software accessories
Device Class
Class I
Special Device Type
Software
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 240f2299-3111-45a7-8e0b-e7511131dabd 61 fields · synced 23 Oct 2026