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DBdirect™ COVID-19 Multiplex RT-PCR Kit

by DIANA Biotechnologies, a.s EUDAMED

Active European Union

Ref DB-1219-100rxns

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08594210150034 Basic UDI-DIDate10 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
DB-1219-100rxns
Primary DI / UDI-DI
08594210150034
Basic UDI-DI
B-08594210150034
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000022346

Other devices from DIANA Biotechnologies, a.s

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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