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RayStation v2025 SP1

by Raysearch Laboratories Ab (Publ) Sweden EUDAMED

Ref 17.0

EMDN Z11019082

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620117938-05 Date28 Sep 2026IssuedStatusActive expires 27 Sep 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620117938-05 Supplemented

    Quality management system EU MDR

    Notified body
    Intertek Medical Notified Body AB 2862
    Issued
    28 Sep 2026
    Expires
    27 Sep 2031
    Reason
    Add device or group

Specification

EUDAMED · synced 23 Oct 2026

Device Name
RayStation
Model / Reference
17.0
Primary DI / UDI-DI
07350002010945
Basic UDI-DI
73500020105HG
Direct Marketing DI
07350002010945
EMDN Code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
SE-MF-000001908

Other devices from RaySearch Laboratories AB (PUBL)

See all devices from RaySearch Laboratories AB (PUBL) →

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 c4e2f7b5-2cf4-424b-a55b-a6501d61ffe5 61 fields · synced 23 Oct 2026