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Raygenic Rayspad

by Onwelo Sp. z o.o. Poland EUDAMED

Ref Raygenic Rayspad

EMDN Z11030592

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590572343860Raygenic7K Basic UDI-DIDate15 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Raygenic Rayspad
Primary DI / UDI-DI
00590572343860
Basic UDI-DI
590572343860Raygenic7K
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000034992

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 50c216ab-9886-42c4-813a-2d0faa457c8b 61 fields · synced 22 Oct 2026