Skip to content

D-Dimer Calibrator

by Nordic Biomarker AB Sweden EUDAMED

Ref SC105K

EMDN W0103020701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7350060320297A Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
D-dimer FEU Calibrator
Model / Reference
SC105K
Primary DI / UDI-DI
27350060320509
Basic UDI-DI
7350060320297A
EMDN Code
W0103020701 Calibration plasma for haemostasis
Device Class
Class C
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000022201

From the manufacturer

Manufacturer's product page: D-dimer DDU Calibrator

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED abbc739b-d106-4e67-a814-87a290adaba1 61 fields · synced 24 Oct 2026