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Clinical Information System FONS Enterprise

by STAPRO s. r. o. EUDAMED

Active European Union

Ref 859419125FEZB

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859419125FEZB Basic UDI-DIDate26 Mar 2025RegisteredStatusActive

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  • Withdrawn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)
  • 2023-MDR/QS-060 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    19 Feb 2025
    Expires
    18 Dec 2028

Specification

EUDAMED

Device Name
Clinical Information System FONS Enterprise
Model / Reference
859419125FEZB
Primary DI / UDI-DI
08594191250013
Basic UDI-DI
859419125FEZB
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000033591

From the manufacturer

Manufacturer's product page: Více informací o FONS Enterprise

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