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Monkeypox Antigen Rapid Test Kit (Immunochromatography)

by Labnovation Technologies, Inc. EUDAMED

Active European Union

Ref LQ-000401Model 20 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06938384622072 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
20 Tests/Kit, LQ-000401
Primary DI / UDI-DI
06938384622072
Market of Registration
Germany

Manufacturer details

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

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