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Allplex™ Meningitis-B Assay

by Seegene, Inc. United States EUDAMED

Ref MG9600Y

EMDN W0105070505

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08809240101049 Basic UDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08809240101049 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MG9600Y
Primary DI / UDI-DI
08809240101049
Basic UDI-DI
B-08809240101049, 924010MG96000HR
EMDN Code
W0105070505 Meningitis / encephalitis infections - multiplex na reagents
Device Class
Class IVD General
Class C
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 (2)

  • EUDAMED 8c736fd8-4785-4408-a63a-e45914760ce9 61 fields · synced 24 Oct 2026
  • EUDAMED 08809240101049|924010MG96000HR 61 fields · synced 24 Oct 2026