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MRX FDP Clear Calibrator Set

by Nordic Biomarker AB Sweden EUDAMED

Ref K5017

EMDN W0103020701

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-27350060320356 Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
FDP Clear Calibrator Set
Model / Reference
K5017
Primary DI / UDI-DI
27350060320356
Basic UDI-DI
B-27350060320356
EMDN Code
W0103020701 Calibration plasma for haemostasis
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000022201

From the manufacturer

Manufacturer's product page: FDP Clear Calibrator

Other devices from Nordic Biomarker AB

See all devices from Nordic Biomarker AB →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4fb82e53-d068-45c8-86ac-fd376f580eb8 61 fields · synced 22 Oct 2026