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Sun Nuclear Advanced Electron Density Phantom 1467

by Sun Nuclear Corporation

Ref 1467

Sun Nuclear Advanced Electron Density Phantom 1467 is a Class I device made by Sun Nuclear Corporation, registered in EUDAMED on 4 Feb 2026 (Basic UDI-DI 5060608881467PHKV) and listed in FDA GUDID since 27 Aug 2021 (UDI-DI 05060608881253), 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 Number5060608881467PHKV Basic UDI-DI 05060608881253UDI-DIDate4 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608881253 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5060608881467PHKV registered 4 Feb 2026 Active
  • FDA GUDID UDI-DI 05060608881253 listed 27 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060608881253
  2. Registered EUDAMED 5060608881467PHKV

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  • Withdrawn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
Advanced Electron Density Phantom EUDAMED
Sun Nuclear Advanced Electron Density Phantom GUDID
Generic name
CT phantom, test object
Model / reference
1467
Primary DI / UDI-DI
05060608881253 EUDAMED
B13614670 GUDID
Basic UDI-DI
5060608881467PHKV
FDA product code
LHO
EMDN code
Z11030599 Radiology instruments - other
GMDN term
CT phantom, test object
Device class
Class I
Regulation number
892.1940
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05060608881253
GUDID
B13614670

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060608881253; FDA GUDID lists B13614670), so their flags are not compared.

From the manufacturer

Manufacturer's product page: Advanced Electron Density Phantom Tissue-Equivalent CT-to-Electron Density Calibration

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - OTHER.

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Properties

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