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Catphan®

by Phantom Laboratory 2 variants

Ref CTP600Model Catphan®

Catphan (CTP600) is a CT phantom (EU MDR Class I; FDA Class I; FDA product code IXF, Test-Pattern, Radiographic) made by Phantom Laboratory, registered in EUDAMED on 6 Apr 2026 (Basic UDI-DI 081226603CTP600WF) and listed in FDA GUDID since 28 Aug 2023 (UDI-DI 00812266030031), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081226603CTP600WF Basic UDI-DI 00812266030031UDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812266030031 UDI-DI Date28 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081226603CTP600WF registered 6 Apr 2026 Active
  • FDA GUDID UDI-DI 00812266030031 listed 28 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812266030031
  2. Registered EUDAMED 081226603CTP600WF

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  • Withdrawn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

Generic name
CT phantom, test object
Device name
CTP600
Model / reference
Catphan®, CTP600
Primary DI / UDI-DI
00812266030031
Basic UDI-DI
081226603CTP600WF
Direct marketing DI
00812266030031
FDA product code
IXF
EMDN code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
GMDN term
CT phantom, test object
Device class
Class I
Regulation number
892.1940
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000027490
Authorised representative
Hoff & Lowendahl AB SE-AR-000001888

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Phantom Laboratory

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Properties

  • Premarket exempt
Other properties (24, all answered No)