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Lupus Anticoagulant Assay Kit (Coagulation Method)

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref NX-0035-05Model CA LA-SCT Specification 3： SCT screen: 4 × 2.0 mL SCT CaCl2: 4 ×2.0 mL EMDN W0103020606

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377305999 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
CA LA-SCT Specification 3： SCT screen: 4 × 2.0 mL SCT CaCl2: 4 ×2.0 mL, NX-0035-05
Primary DI / UDI-DI
06941377305999
Basic UDI-DI
B-06941377305999
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

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 6bb6c7ea-c561-4df0-803d-950f593647e5 61 fields · synced 24 Oct 2026