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Biograph mCT Flow Edge - 4R combi

by Siemens Medical Solutions USA, Inc.

Ref 11521507Model MDR_SPPP_11_IIb_HES_Comb.PET-CT

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686902226VD Basic UDI-DI 04056869979991UDI-DIDate15 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MDR_SPPP_11_IIb_HES_Comb.PET-CT
Model / Reference
MDR_SPPP_11_IIb_HES_Comb.PET-CT, 11521507
Primary DI / UDI-DI
04056869979991
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

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Properties

Other properties (1)

  • Sterile: No