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CTP764

by Phantom Laboratory

Ref CTP764

CTP764 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 18 Mar 2025 (Basic UDI-DI 081226603CTP764XE) and listed in FDA GUDID since 13 Jan 2025 (UDI-DI 00812266031403), 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 Number081226603CTP764XE Basic UDI-DI 00812266031403UDI-DIDate18 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00812266031403 UDI-DI Date13 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081226603CTP764XE registered 18 Mar 2025 Active
  • FDA GUDID UDI-DI 00812266031403 listed 13 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812266031403
  2. Registered EUDAMED 081226603CTP764XE

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  • Withdrawn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
Catphan®
Generic name
CT phantom, test object
Device name
CTP764
Model / Ref / Catalog
CTP764
Primary DI / UDI-DI
00812266031403
Basic UDI-DI
081226603CTP764XE
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)