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Clostridium difficile GDH kasetki 20 szt

by BioMaxima Spółka Akcyjna EUDAMED

Active European Union

Ref 1-321-K020, 1-320-K020

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439BRT320JA Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Clostridium difficile GDH kasetki 20 szt
Model / Reference
1-321-K020, 1-320-K020
Primary DI / UDI-DI
05902643958371, 05902643958364
Basic UDI-DI
59026439BRT320JA
EMDN Code
W0105090106, W0105090199
Device Class
Class B
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties

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