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Qfr

by Medis Medical Imaging Systems bv Netherlands EUDAMED

Ref 9.51.450.2025Model Medis QFR XA

EMDN Z12050582

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B141MEDISQFRXAJN Basic UDI-DIDate16 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Medis QFR XA
Model / Reference
Medis QFR XA, 9.51.450.2025
Primary DI / UDI-DI
MEDISQFRXA20250
Basic UDI-DI
++B141MEDISQFRXAJN
Direct Marketing DI
MEDISQFRXA20250
EMDN Code
Z12050582 Cardiac output measurement instruments - software accessories
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002670

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f1ea6adf-1407-4287-953c-18f68bd83b2a 61 fields · synced 22 Oct 2026