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RayStation 8.0.1

by RaySearch Laboratories AB (PUBL)

Ref RS 8A SP1

RayStation 8.0.1 is a radiation therapy software (EU MDD Class IIb; FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by RaySearch Laboratories AB (PUBL), registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-07350002010136) and listed in FDA GUDID since 30 Sep 2021 (UDI-DI 07350002010136), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350002010136 Basic UDI-DI 07350002010136UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010136 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07350002010136 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 07350002010136 listed 30 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350002010136
  2. Registered EUDAMED B-07350002010136

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Rs 8A SP1 EUDAMED
RayStation GUDID
Generic name
Radiation therapy software
Device name
RayStation 8A SP1
Model / reference
RS 8A SP1 EUDAMED
8.0.1 GUDID
Primary DI / UDI-DI
07350002010136
Basic UDI-DI
B-07350002010136
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
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RS 8A SP1
GUDID
8.0.1
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 (21, all answered No)