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RealAccurate® Quadruplex Corona PCR kit

by PathoFinder B.V. Netherlands EUDAMED

Ref PF0971-R EMDN W0105041106

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08719326569918 Basic UDI-DIDate8 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  • Withdrawn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 · synced 23 Oct 2026

Model / Reference
PF0971-R
Primary DI / UDI-DI
08719326569918
Basic UDI-DI
B-08719326569918
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002704

From the manufacturer

Manufacturer's product page: RealAccurate® technologyQuadruplex real-time PCR

Other devices from PathoFinder B.V.

See all devices from PathoFinder B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 79c272f6-a0ee-43ed-8c84-67ba622b19d1 61 fields · synced 23 Oct 2026