Skip to content

Allplex™ MTB/MDR/XDRe Detection

by Seegene, Inc. United States EUDAMED

Ref TB10385Z

EMDN W0105010799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809240103852 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
TB10385Z
Primary DI / UDI-DI
08809240103852
Basic UDI-DI
B-08809240103852
EMDN Code
W0105010799 Mycobacteria reagents - other
Device Class
Class IVD General
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 (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5e8e6943-1095-4968-ad3f-32e6b136e4eb 61 fields · synced 23 Oct 2026