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eazyplex® SuperBug CRE

by AmplexDiagnostics GmbH Germany EUDAMED

Ref 7600

EMDN W0104080608

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42505923CRENKT 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 CRE
Model / Reference
7600
Primary DI / UDI-DI
04250592376007
Basic UDI-DI
42505923CRENKT
EMDN Code
W0104080608 Nucleic acid identification - manual / automated esbl / carbapenemase combined
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 badf2ebe-6fc7-476b-9319-0cbbfd093bfa 61 fields · synced 22 Oct 2026