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System SOMATOM X.ceed 11330002

by Siemens Healthineers EUDAMEDGUDID

Active European Union

Ref 11330002Model MDR_03_II b_FOR S3_CT_Scanner

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686902298W6 Basic UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04068151995008 UDI-DIDate7 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
SOMATOM X.ceed EUDAMED
System SOMATOM X.ceed GUDID
Generic Name
Full-body CT system
Device Name
MDR_03_II b_FOR S3_CT_Scanner
Model / Reference
11330002, MDR_03_II b_FOR S3_CT_Scanner
Primary DI / UDI-DI
04068151995008
Basic UDI-DI
0405686902298W6
510(k) Number
FDA Product Code
JAK
EMDN Code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
GMDN Term
Full-body CT system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
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 (K253574)

Other devices from Siemens Healthineers

See all devices from Siemens Healthineers →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No