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ACCENT-300 IgA

by PZ CORMAY Spółka Akcyjna EUDAMED

Active European Union

Ref 7-302Model ACCENT-300

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514602100 Basic UDI-DIDate16 Feb 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  • Withdrawn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

Device Name
IgA
Model / Reference
ACCENT-300, 7-302
Primary DI / UDI-DI
05907514602100
Basic UDI-DI
B-05907514602100
EMDN Code
W0102010101 Immunoglobulin a
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No