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Fistura pack

by F Care Systems Belgium EUDAMED

Ref 06FISPACK6F

EMDN K01020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number542502563-PPF001-Y4 Basic UDI-DIDate20 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Fistura pack
Model / Reference
06FISPACK6F
Primary DI / UDI-DI
05425025630714
Basic UDI-DI
542502563-PPF001-Y4
EMDN Code
K01020199 Minimally invasive surgery surgical instrument kits, single-use - other
Device Class
Class I
Medical Purpose
Procedure pack for treatment of anal fistula using radiofrequency thermocoagulation

Manufacturer details

EUDAMED SRN
BE-PR-000000039

From the manufacturer

Manufacturer's product page: Fistura Pack

Other devices from F Care Systems

See all devices from F Care Systems →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 573b7679-89e5-4c65-bf87-10c9267deda6 61 fields · synced 24 Oct 2026