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KMScreen DICOM SOFTWARE PLUS

by Ortho Km Sweden EUDAMED

Ref KMScreen DICOM SOFTWARE PLUSModel KMScreen SDL FULL

EMDN Z1212012004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7350115200431S2 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
KMScreen SDL FULL
Model / Reference
KMScreen SDL FULL, KMScreen DICOM SOFTWARE PLUS
Primary DI / UDI-DI
73501152025720
Basic UDI-DI
7350115200431S2
Direct Marketing DI
73501152025720
EMDN Code
Z1212012004 Hess screens
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000044308

Other devices from Ortho Km

See all devices from Ortho Km →

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 84cf1b6a-9a23-41ee-a4e1-07a9ead4aead 61 fields · synced 24 Oct 2026