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syngo Application Software 11831234

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11831234Model MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900143US Basic UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04068151018226 UDI-DIDate15 May 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
syngo Application Software
Generic Name
Basic x-ray clinical assessment support software
Device Name
MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)
Model / Reference
11831234, MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)
Primary DI / UDI-DI
04068151018226
Basic UDI-DI
0405686900143US
510(k) Number
FDA Product Code
QIH
EMDN Code
Z11030192 Digital angiography systems - medical device software
GMDN Term
Basic x-ray clinical assessment support software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050
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 IIb
GUDID
Class II

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No