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PC-Software EasyScore

by Dr. Fenyves und Gut Deutschland GmbH

Ref 925310

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number42519786040062U Basic UDI-DI 04251978600563UDI-DIDate2 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
PC-Software OR5
Model / Reference
925310
Primary DI / UDI-DI
04251978600563
Basic UDI-DI
42519786040062U
Direct Marketing DI
04251978600563
EMDN Code
Z12100582 Polysomnography instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005715

Other devices from Dr. Fenyves und Gut Deutschland GmbH

See all devices from Dr. Fenyves und Gut Deutschland GmbH →

Properties

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