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Rafaelo pack

by F Care Systems Belgium EUDAMED

Ref 06RAFAELOPACKModel Rafaelo pack

EMDN K01020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number542502563-PPH001-YS Basic UDI-DIDate20 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Rafaelo pack, 06RAFAELOPACK
Primary DI / UDI-DI
05425025630165
Basic UDI-DI
542502563-PPH001-YS
EMDN Code
K01020199 Minimally invasive surgery surgical instrument kits, single-use - other
Device Class
Class I
Medical Purpose
Pack containing all items used during radiofrequency thermocoagulation of hemorrhoids

Manufacturer details

EUDAMED SRN
BE-PR-000000039

From the manufacturer

Manufacturer's product page: Rafaelo 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 db8197ec-2026-4669-87b6-2bb1233a3185 61 fields · synced 22 Oct 2026