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Sun Nuclear Advanced iqModule 1464

by Sun Nuclear Corporation

Ref 1464

Sun Nuclear Advanced iqModule 1464 is a Class I device made by Sun Nuclear Corporation, registered in EUDAMED on 7 Jan 2026 (Basic UDI-DI 506060888PH1464ZH) and listed in FDA GUDID since 27 Aug 2021 (UDI-DI 05060608881246), 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 Number506060888PH1464ZH Basic UDI-DI 05060608881246UDI-DIDate7 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608881246 UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506060888PH1464ZH registered 7 Jan 2026 Active
  • FDA GUDID UDI-DI 05060608881246 listed 27 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060608881246
  2. Registered EUDAMED 506060888PH1464ZH

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  • Withdrawn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 iqMODULES EUDAMED
Sun Nuclear Advanced iqModule GUDID
Generic name
CT phantom, test object
Model / reference
1464
Primary DI / UDI-DI
05060608881246 EUDAMED
B13614640 GUDID
Basic UDI-DI
506060888PH1464ZH
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
05060608881246
GUDID
B13614640

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060608881246; FDA GUDID lists B13614640), so their flags are not compared.

From the manufacturer

Manufacturer's product page: Sun Nuclear Patents

Related devices

Category: CT phantom, test object

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - OTHER.

Other devices from Sun Nuclear Corporation

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Properties

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