Skip to content

Allplex™ STI Essential Assay Q(MH, UU)

by Seegene, Inc. 3 variants

Ref SD10318Z

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number924010SD10202G4 Basic UDI-DI 08809240103180UDI-DIDate7 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
SD10318Z
Primary DI / UDI-DI
08809240103180
Basic UDI-DI
924010SD10202G4
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
Device Class
Class C
EU 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

  • 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