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Synapse Workflow Es

by Fujifilm Healthcare Italia S.P.A.

Ref SYNAPSE WORKFLOW ES

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805699280SYNAPSEWFESEQ Basic UDI-DI 08056992800021UDI-DIDate5 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
SYNAPSE WORKFLOW ES
Primary DI / UDI-DI
08056992800021
Basic UDI-DI
805699280SYNAPSEWFESEQ
Direct Marketing DI
08056992800021
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class I
Special Device Type
Software
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029974

Other devices from Fujifilm Healthcare Italia S.P.A.

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