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Anti-PR3 Assay Kit (Fluorescence Immunoassay)

by DiYaLab ZJG Biotech Co., Ltd China EUDAMED

Ref 20T EMDN W0102100403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975424221857 Basic UDI-DIDate18 Jul 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  • Withdrawn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
20T
Primary DI / UDI-DI
06975424221857
Basic UDI-DI
B-06975424221857
EMDN Code
W0102100403 Pr3 anca
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 (1)

  • EUDAMED f6b1715f-bf52-45fc-867a-0e923f58adc6 61 fields · synced 22 Oct 2026