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COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones

by Sistemas Genomicos. S.L. Spain EUDAMED

Ref LV4452Model COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones

EMDN W0105040519

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436566762809 Basic UDI-DIDate12 Dec 2022RegisteredStatusActive

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 22 Oct 2026

Model / Reference
COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones, LV4452
Primary DI / UDI-DI
08436566762809
Basic UDI-DI
B-08436566762809
EMDN Code
W0105040519
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000022949

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 ec958eb6-7ab6-45e8-b66f-ed89278bdb41 61 fields · synced 22 Oct 2026