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One Step Ebola IgG/IgM Test

by Newlink Biotech co., Ltd. EUDAMED

Active European Union

Ref L11-EB01C4

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-L11-EB01C4WV Basic UDI-DIDate1 Sep 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  • Withdrawn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
L11-EB01C4
Primary DI / UDI-DI
D-L11-EB01C4WV
Basic UDI-DI
B-L11-EB01C4WV
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000045176
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Newlink Biotech co., Ltd.

See all devices from Newlink Biotech co., Ltd. →

Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No