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Quantia D-Dimer Standard

by Biokit S.A. Spain EUDAMED

Ref 7K02-11

EMDN W0103020701

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8436003070542XH Basic UDI-DIDate17 Aug 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
Quantia D-Dimer
Model / Reference
7K02-11
Primary DI / UDI-DI
00380740174194
Basic UDI-DI
8436003070542XH
EMDN Code
W0103020701 Calibration plasma for haemostasis
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000002406

Other devices from Biokit, S.A.

See all devices from Biokit, S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00380740174194|8436003070542XH 61 fields · synced 24 Oct 2026