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LUMINOS Impulse

by Siemens Shanghai Medical Equipment Ltd. United States EUDAMED

Ref 11506518Model MDR_16_II b_SHA NH_ACDV_FLOURO_DIGITAL_SSME_XP

EMDN Z11039009

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686901997WY Basic UDI-DIDate3 Jun 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_16_II b_SHA NH_ACDV_FLOURO_DIGITAL_SSME_XP
Model / Reference
MDR_16_II b_SHA NH_ACDV_FLOURO_DIGITAL_SSME_XP, 11506518
Primary DI / UDI-DI
04056869281865
Basic UDI-DI
0405686901997WY
EMDN Code
Z11039009 Fluoroscopy devices
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000013434
Authorised representative
Siemens Healthcare GmbH DE-AR-000011241

Other devices from Siemens Shanghai, Medical Equipment Ltd.

See all devices from Siemens Shanghai, Medical Equipment Ltd. →

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 8b27d9a7-dc2d-43c2-97c4-4f090fe9d6a2 61 fields · synced 24 Oct 2026