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Fistura

by F Care Systems Belgium EUDAMED

Ref 05FIS8FModel 8F (05FIS8F)

EMDN K02010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05425025630486 Basic UDI-DIDate11 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Fistura catheter
Model / Reference
8F (05FIS8F), 05FIS8F
Primary DI / UDI-DI
05425025630486
Basic UDI-DI
B-05425025630486
EMDN Code
K02010199 Mono- and bipolar instruments, single-use - other
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000037

Other devices from F Care Systems

See all devices from F Care Systems →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 42a8db60-d22a-4f6a-8163-6a6acd59ed81 61 fields · synced 23 Oct 2026