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Functional Fibrinogen Assay

by Medcaptain Medical Technology Co., Ltd. United States EUDAMED

Ref MCT01501E

EMDN W0103020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69268026MD78D000000000143 Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Functional Fibrinogen Assay
Model / Reference
MCT01501E
Primary DI / UDI-DI
06926802615539
Basic UDI-DI
69268026MD78D000000000143
EMDN Code
W0103020201 Fibrinogen assays (factor i)
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000005925
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Medcaptain Medical Technology Co., Ltd.

See all devices from Medcaptain Medical Technology Co., Ltd. →

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 06926802615539|69268026MD78D000000000143 61 fields · synced 25 Oct 2026