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Dicompass Gateway

by MEDORO s.r.o.

Ref 1

Expiring European Union

CE MDR

Valid until

9 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859421232DICOMPASSGM Basic UDI-DI 08594212320015UDI-DIDate22 Jul 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-020 Expiring Amended Expires in 312 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    19 Mar 2025
    Expires
    9 Sep 2027
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Dicompass
Model / Reference
1
Primary DI / UDI-DI
08594212320015
Basic UDI-DI
859421232DICOMPASSGM
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000024306

Other devices from MEDORO s.r.o.

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No