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Allplex™ MDRO Assay

by Seegene, Inc. United States EUDAMED

Ref MR10288Z

EMDN W0104080607

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number924010MR10289KS Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MR10288Z
Primary DI / UDI-DI
08809240102886
Basic UDI-DI
924010MR10289KS
EMDN Code
W0104080607 Nucleic acid identification - manual / automated other resistance markers
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000022275
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Seegene Inc.

See all devices from Seegene Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 22150895-b335-4150-a1ba-71f65031d89d 61 fields · synced 24 Oct 2026