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SurPass

by DataRiver S.r.l. Italy EUDAMED

Ref SP200

EMDN Z12040192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805257075SP20098 Basic UDI-DIDate28 Sep 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

Model / Reference
SP200
Primary DI / UDI-DI
08052570750023
Basic UDI-DI
805257075SP20098
Direct Marketing DI
08052570750023
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000038324

Other devices from DataRiver S.r.l.

  • Aria

    Class IIa

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 b306df3d-373e-451e-a4bb-d79342bb8cd0 61 fields · synced 24 Oct 2026