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ART-Plan v.1.10.0

by Therapanacea Sas

Ref ART-Plan

ART-Plan v.1.10.0 is a device classified as Class IIb in the EU and Class II in the US made by Therapanacea Sas, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 3770019940ARTPLANN4) and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 03770019940006), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770019940ARTPLANN4 Basic UDI-DI 03770019940006UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03770019940006 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3770019940ARTPLANN4 registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 03770019940006 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03770019940006
  2. Registered EUDAMED 3770019940ARTPLANN4

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  • Withdrawn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
ART-Plan
Generic name
Radiation therapy software
Model / reference
ART-Plan EUDAMED
v.1.10.0 GUDID
Primary DI / UDI-DI
03770019940006
Basic UDI-DI
3770019940ARTPLANN4
FDA product code
QKB, LLZ, MUJ
EMDN code
Z11010482 Radiotherapy treatment planning instruments - software accessories
GMDN term
Radiation therapy software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050, 892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ART-Plan
GUDID
v.1.10.0
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 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS.

Other devices from Therapanacea Sas

See all devices from Therapanacea Sas →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)