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BIOGRAPH One

by Siemens Healthineers AG Germany EUDAMED

Ref 11689624Model MDR_02_IIa_FOR AG S3_ACDV_mMR

EMDN Z11020701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686902280VK Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
MDR_02_IIa_FOR AG S3_ACDV_mMR
Model / Reference
MDR_02_IIa_FOR AG S3_ACDV_mMR, 11689624
Primary DI / UDI-DI
04068151055191
Basic UDI-DI
0405686902280VK
EMDN Code
Z11020701 MRI/pet systems
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000038456

Other devices from Siemens Healthineers AG

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 04068151055191|0405686902280VK 61 fields · synced 24 Oct 2026