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Infliximab Determination Kit (Fluorescence Immunochromatographic Assay)

by Beijing Diagreat Biotechnologies Co., Ltd. EUDAMED

Active European Union

Ref P11423Model 25 tests/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697518250P114236A Basic UDI-DIDate4 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
25 tests/box, P11423
Primary DI / UDI-DI
06942293581306
Basic UDI-DI
697518250P114236A
Direct Marketing DI
06942293581306
EMDN Code
W0102080701 Infliximab
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019511
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties

Show properties
  • Sterile
  • Reagent
  • Professional Testing
  • New Device
Other properties (7)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No