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Protein C Activity Testing Kit(Chromogenic Substrate Method)

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref NX-0078-02Model CA-PC specification 2：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL, PC diluent: 2×5.0 mL

EMDN W0103020607

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377307641 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

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

Model / Reference
CA-PC specification 2：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL, PC diluent: 2×5.0 mL, NX-0078-02
Primary DI / UDI-DI
06941377307641
Basic UDI-DI
B-06941377307641
EMDN Code
W0103020607 Protein c
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.

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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 06941377307641|B-06941377307641 61 fields · synced 24 Oct 2026