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Fibrinogen (FIB) Test Kit (Coagulation)

by Biobase Biodustry(Shandong) Co., Ltd. EUDAMED

Active European Union

Ref Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936895303497 Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Fibrinogen (FIB) Assay Kit (Coagulation)
Model / Reference
Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）
Primary DI / UDI-DI
06936895303497
Basic UDI-DI
B-06936895303497
EMDN Code
W0103020201 Fibrinogen assays (factor i)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No