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eazyplex® BloodScreen GP A

by AmplexDiagnostics GmbH Germany EUDAMED

Ref 7677

EMDN W0104080699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42505923BSGPL3 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® BloodScreen GP A
Model / Reference
7677
Primary DI / UDI-DI
04250592376779
Basic UDI-DI
42505923BSGPL3
EMDN Code
W0104080699 Nucleic acid identification (bacteriology) manual / automated - 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 ffac2d6a-174f-4d24-bf76-a4a93f34cee9 61 fields · synced 22 Oct 2026