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RayStation 11B SP2

by RaySearch Laboratories AB (PUBL)

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

Ref RayStation 12.0

RayStation 11B SP2 is a device classified as Class IIb in the EU and Class II in the US made by RaySearch Laboratories AB (PUBL), registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 73500020101H8) and listed in FDA GUDID since 3 May 2022 (UDI-DI 07350002010501), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

27 Sep 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73500020101H8 Basic UDI-DI Date4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010501 UDI-DI Date3 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 73500020101H8 registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 07350002010501 listed 3 May 2022 Listed

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

Timeline

2 dated events

  1. Listed FDA GUDID 07350002010501
  2. Registered EUDAMED 73500020101H8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
RayStation 11B SP2 EUDAMED
RayStation 11B EUDAMED
RayStation GUDID
Generic name
Radiation therapy software
Model / reference
RayStation 12.0 EUDAMED
11B SP2 GUDID
11B GUDID
Primary DI / UDI-DI
07350002010501, 07350002010426
Basic UDI-DI
73500020101H8
Direct marketing DI
07350002010501
07350002010426
FDA product code
MUJ
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
GMDN term
Radiation therapy software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RayStation 12.0
GUDID
11B SP2
11B
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

Other devices from RaySearch Laboratories AB (PUBL)

See all devices from RaySearch Laboratories AB (PUBL) →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)