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Fibrinogen Assay Kit (Modified Clauss Method)

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref NX-0051-02Model CA-FIB(L) Specification 2:R1: 4.0 mL× 10, R2: 30.0 mL× 5 EMDN W0103020201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377308754 Basic UDI-DIDate20 Sep 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
CA-FIB(L) Specification 2:R1: 4.0 mL× 10, R2: 30.0 mL× 5, NX-0051-02
Primary DI / UDI-DI
06941377308754
Basic UDI-DI
B-06941377308754
EMDN Code
W0103020201 Fibrinogen assays (factor i)
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

See all devices from Shenzhen Dymind Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 06941377308754|B-06941377308754 61 fields · synced 25 Oct 2026