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Chemistry Analyzer Model: ACCENT S120

by PZ CORMAY Spółka Akcyjna EUDAMED

Active European Union

Ref B04-A0001Model ACCENT S120

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59075146AccentS120TW Basic UDI-DIDate13 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Chemistry Analyzer
Model / Reference
ACCENT S120, B04-A0001
Primary DI / UDI-DI
05907514600229
Basic UDI-DI
59075146AccentS120TW
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

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Properties

  • 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