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syngo.CT Dual Energy 11664607

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11664607Model syngo.CT PP_IIa_App_ERLN H 127

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900118UT Basic UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869958934 UDI-DIDate21 Nov 2025ListedStatusListed 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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
syngo.CT Dual Energy
Generic Name
CT system application software
Device Name
syngo.CT PP_IIa_App_ERLN H 127
Model / Reference
11664607, syngo.CT PP_IIa_App_ERLN H 127
Primary DI / UDI-DI
04056869958934
Basic UDI-DI
0405686900118UT
510(k) Number
FDA Product Code
JAK
EMDN Code
Z11030682 Computed tomographs (CT) - software accessories
GMDN Term
CT system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1750
Special Device Type
Software
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K241757)

Other devices from Siemens Healthcare

See all devices from Siemens Healthcare →

Properties

Other properties (24)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No