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ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

by Biosystems S.A. Spain EUDAMED

Ref 50055

EMDN W0102100499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08012992500552 Basic UDI-DIDate22 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)
Model / Reference
50055
Primary DI / UDI-DI
08012992500552
Basic UDI-DI
B-08012992500552
EMDN Code
W0102100499 Vasculitis - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

Other devices from Biosystems S.A.

See all devices from Biosystems S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 0c591fde-f445-465c-9966-67004939a1f5 61 fields · synced 22 Oct 2026