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Chemistry Analyzer ACCENT-400

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref B08-A0001Model ACCENT-400

EMDN W0201010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59075146Accent400SS Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Chemistry Analyzer
Model / Reference
ACCENT-400, B08-A0001
Primary DI / UDI-DI
05907514601691
Basic UDI-DI
59075146Accent400SS
EMDN Code
W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

Other devices from PZ CORMAY Spółka Akcyjna

See all devices from PZ CORMAY Spółka Akcyjna →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED cd3f47c1-9f9b-4129-bcea-75ee04d7aa60 61 fields · synced 24 Oct 2026