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Allplex™ Vaginitis Screening Assay

by Seegene, Inc. United States EUDAMED

Ref SD10321Z

EMDN W0105070502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08809240103210 Basic UDI-DIDate13 May 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08809240103210 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 22 Oct 2026

Model / Reference
SD10321Z
Primary DI / UDI-DI
08809240103210
Basic UDI-DI
B-08809240103210, 924010SD97500LQ
EMDN Code
W0105070502 Other multiple infectious - 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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 422b82bd-5c43-444e-90cb-f6e024245a3f 61 fields · synced 22 Oct 2026
  • EUDAMED 08809240103210|924010SD97500LQ 61 fields · synced 21 Oct 2026