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eazyplex® hv-K.pneumoniae

by AmplexDiagnostics GmbH Germany EUDAMED

Ref 7858 EMDN W0105011699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42505923HVKPN8 Basic UDI-DIDate3 Sep 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
eazyplex® hv-K.pneumoniae
Model / Reference
7858
Primary DI / UDI-DI
04250592378582
Basic UDI-DI
42505923HVKPN8
EMDN Code
W0105011699 Bacteriology - na reagents - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000014117

Other devices from AmplexDiagnostics GmbH

See all devices from AmplexDiagnostics GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED b6116840-a6bf-4644-8839-b40a9711b0a6 61 fields · synced 22 Oct 2026