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Fdr-2000BPY

by FUJIFILM Corporation Japan EUDAMED

Ref 04547410242294

EMDN Z1103028001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number454741010100000000000894A Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Biopsy Positioner
Model / Reference
04547410242294
Primary DI / UDI-DI
04547410242294
Basic UDI-DI
454741010100000000000894A
EMDN Code
Z1103028001 Stereotactic modules for mammography
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

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 6d470978-3276-4d14-ae7b-88002019822a 61 fields · synced 22 Oct 2026