Skip to content

Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit

by Sansure Biotech Inc. United States EUDAMED

Ref S2018E-75

EMDN W0103020502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06955792737327 Basic UDI-DIDate6 Sep 2023RegisteredStatusActive

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 24 Oct 2026

Device Name
Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit
Model / Reference
S2018E-75
Primary DI / UDI-DI
06955792737327
Basic UDI-DI
B-06955792737327
EMDN Code
W0103020502 Fibrinogen degradation products
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sansure Biotech Inc.

See all devices from Sansure Biotech Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED a53eb997-c094-41e1-ac5d-538953a1f2d4 61 fields · synced 24 Oct 2026