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SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography)

by Labnovation Technologies, Inc. China EUDAMED

Ref LX-401301Model 20 Tests/Kit

EMDN W0105090501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06938384622089 Basic UDI-DIDate22 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
20 Tests/Kit, LX-401301
Primary DI / UDI-DI
06938384622089
Basic UDI-DI
B-06938384622089
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015953
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Labnovation Technologies, Inc.

See all devices from Labnovation Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 51fcd72c-b112-44dd-b1cf-f22f946b5574 61 fields · synced 23 Oct 2026