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Biograph Vision Quantum

by Siemens Medical Solutions USA, Inc.

Ref 11715678Model PET-CT_11_IIb_HES

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 Number0405686900133UP Basic UDI-DI 04068151048865UDI-DIDate28 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
PET-CT_11_IIb_HES
Model / Reference
PET-CT_11_IIb_HES, 11715678
Primary DI / UDI-DI
04068151048865
Basic UDI-DI
0405686900133UP
EMDN Code
Z11020301 CT/pet systems
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
US-MF-000016485
Authorised representative
Siemens Healthcare GmbH DE-AR-000011241

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Properties

Other properties (13)

  • Sterile: 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