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CP-BU M 18x24

by Agfa Corp.

Ref XDAOG

CP-BU M 18x24 (XDAOG) is a device classified as Class IIa in the EU and Class I in the US made by Agfa Corp., registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI B-05414904237793) and listed in FDA GUDID since 25 Oct 2022 (UDI-DI 05414904237793), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05414904237793 Basic UDI-DI 05414904237793UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414904237793 UDI-DI Date25 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05414904237793 registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI 05414904237793 listed 25 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05414904237793
  2. Registered EUDAMED B-05414904237793

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  • Withdrawn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
Cp-Bu M
Generic name
Medical x-ray film, screen
Device name
Screen Film
Model / Ref / Catalog
XDAOG, CP-BU M 18x24
Primary DI / UDI-DI
05414904237793
Basic UDI-DI
B-05414904237793
FDA product code
IWZ
EMDN code
Z130101 General purpose x-ray films
GMDN term
Medical x-ray film, screen
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1840
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 18 Centimeter
Width — 24 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
XDAOG
GUDID
CP-BU M 18x24
Device classEUDAMED
Class IIa
GUDID
Class I

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

Similar devices in this category

Other devices filed under X-RAY FILMS.

Other devices from Agfa Corp.

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)