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RayStation 2024B

by Raysearch Laboratories Ab (Publ)

Part of a family of 11 devices: see the family page

Ref RayStation16.0

RayStation 2024B (RayStation16.0) is a Class IIb device made by RaySearch Laboratories AB (PUBL), registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 73500020101H8), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

27 Sep 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73500020101H8 Basic UDI-DI 07350002010778UDI-DIDate4 Aug 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620117938-05 Active Supplemented

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
RayStation
Model / reference
RayStation16.0
Primary DI / UDI-DI
07350002010778
Basic UDI-DI
73500020101H8
Direct marketing DI
07350002010778
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
Device class
Class IIb
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
SE-MF-000001908

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Properties

Other properties (14, all answered No)