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ulrichINJECT CT motion XD 8000

by Ulrich GmbH & Co. KG

Ref XD 8000Model CT motion

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4052536000044PY Basic UDI-DI 04052536230495UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04052536230495 UDI-DI Date2 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
ulrichINJECT CT motion
Generic Name
CT contrast medium injection system, line-powered, mobile
Model / Ref / Catalog
XD 8000, CT motion
Primary DI / UDI-DI
04052536230495
Basic UDI-DI
4052536000044PY
Direct Marketing DI
04052536230495
510(k) Number
FDA Product Code
IZQ
EMDN Code
Z11039014 Multiple contrast agent injectors
GMDN Term
CT contrast medium injection system, line-powered, mobile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K251295)

Other devices from Ulrich GmbH & Co. KG

See all devices from Ulrich GmbH & Co. KG →

Properties

  • Administering Medicine
  • Prescription Use
  • Combination Product
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No