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eazyplex® SuperBug Acineto

by AmplexDiagnostics GmbH Germany EUDAMED

Ref 7607

EMDN W0104080606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42505923SBABKP Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
eazyplex® SuperBug Acineto
Model / Reference
7607
Primary DI / UDI-DI
04250592376076
Basic UDI-DI
42505923SBABKP
EMDN Code
W0104080606 Nucleic acid identification - manual / automated carbapenemase
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 71a7a585-af78-4b0a-91a0-59670d36870b 61 fields · synced 22 Oct 2026