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FilmQA Pro 8.0

by Ashland Specialty Ingredients, G.P.

Ref 987957

FilmQA Pro 8.0 (987957) is a device classified as Class I in the EU and Class II in the US made by Ashland Specialty Ingredients, G.P., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 0850000065FILMQAM5) and listed in FDA GUDID since 12 Feb 2025 (UDI-DI 00810106410845), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850000065FILMQAM5 Basic UDI-DI 00810106410845UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810106410845 UDI-DI Date12 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850000065FILMQAM5 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00810106410845 listed 12 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810106410845
  2. Registered EUDAMED 0850000065FILMQAM5

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  • Withdrawn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
FilmQA Pro™ Software EUDAMED
FilmQA Pro GUDID
Generic name
Radiation therapy software
Model / Ref / Catalog
987957, 8.0
Primary DI / UDI-DI
00810106410845
Basic UDI-DI
0850000065FILMQAM5
FDA product code
MWW
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Radiation therapy software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
987957
GUDID
8.0
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Ashland Specialty Ingredients, G.P.

See all devices from Ashland Specialty Ingredients, G.P. →

Properties

  • Prescription use
  • Premarket exempt
Other properties (23, all answered No)