Skip to content

Anti-aPS/PT IgG CLIA Assay Kit

by DiYaLab ZJG Biotech Co., Ltd China EUDAMED

Ref 100 tests/kit, CL30302EModel 100tests/kit EMDN W0102100502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975424222366 Basic UDI-DIDate22 Dec 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
100 tests/kit, 100tests/kit, CL30302E
Primary DI / UDI-DI
06975424222366, 06975424222847
Basic UDI-DI
B-06975424222366, B-06975424222847
EMDN Code
W0102100502 Anti-phosphatidylserin antibodies
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048648
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from DiYaLab ZJG Biotech Co., Ltd

See all devices from DiYaLab ZJG Biotech Co., Ltd →

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 (2)

  • EUDAMED 2020014b-bfbb-4c1c-8845-be0cd53fe3dc 61 fields · synced 22 Oct 2026
  • EUDAMED 06975424222847|B-06975424222847 61 fields · synced 10 Jul 2026