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Lupus Anticoagulant Assay Kit (Coagulation Method)

by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref NX-0035-02Model CA LA-SCT Specification 2： SCT screen: 4 × 2.0 mL SCT confirm: 4 × 2.0 mL SCT CaCl2: 4 × 4.0 mL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377305982 Basic UDI-DIDate27 Mar 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  • Withdrawn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

Model / Reference
CA LA-SCT Specification 2： SCT screen: 4 × 2.0 mL SCT confirm: 4 × 2.0 mL SCT CaCl2: 4 × 4.0 mL, NX-0035-02
Primary DI / UDI-DI
06941377305982
Basic UDI-DI
B-06941377305982
EMDN Code
W0103020606 Lupus anticoagulant
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

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

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Properties

Show 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