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Fenix

by EL.CO. S.r.l. EUDAMED

Active European Union

Ref 8059575510003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.22/4997.1 Date29 May 2025IssuedStatusActive expires 28 Nov 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.22/4997.1 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    29 May 2025
    Expires
    28 Nov 2027

Specification

EUDAMED

Model / Reference
8059575510003
Primary DI / UDI-DI
08059575510003
Basic UDI-DI
805957551FENIXSUITE20228C
Direct Marketing DI
08059575510003
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029405

Other devices from EL.CO. S.r.l.

  • Fenix

    Class IIa

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