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Biograph Trinion EP2 CT128 Combi

by Siemens Medical Solutions USA, Inc. United States EUDAMED

Ref 11591547Model MDR_SPPP_11_IIb_HES_Comb.PET-CT EMDN Z11020301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686902226VD Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
MDR_SPPP_11_IIb_HES_Comb.PET-CT
Model / Reference
MDR_SPPP_11_IIb_HES_Comb.PET-CT, 11591547
Primary DI / UDI-DI
04056869996745
Basic UDI-DI
0405686902226VD
EMDN Code
Z11020301 CT/pet systems
Device Class
Class IIb
Medical Purpose
PET/CT Diagnostic Imaging System

Manufacturer details

EUDAMED SRN
US-PR-000020471

Other devices from Siemens Medical Solutions USA, Inc.

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 04056869996745|0405686902226VD 61 fields · synced 25 Oct 2026