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O4C

by Dedalus Italia SpA Italy EUDAMED

Ref O4C

EMDN V92

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805572803O4CK2 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00290-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    31 Jan 2026
    Expires
    15 Nov 2027

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
O4C
Primary DI / UDI-DI
08055728030947
Basic UDI-DI
805572803O4CK2
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009127

Other devices from Dedalus Italia SpA

  • GiPSEweb (mobile)

    Class IIb

  • P4C

    Class IIb

  • O4C

    Class IIb

  • ER4H FirstAid Web

    Class IIb

  • GiPSEweb

    Class IIb

  • ER4H FirstAid Web (Mobile)

    Class IIb

See all devices from Dedalus Italia SpA →

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 5a0a8ff7-46d7-40c6-9357-2d7e78cc9907 61 fields · synced 22 Oct 2026