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Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit

by Poly Diagnostics Luxembourg EUDAMED

Ref PD125D48

EMDN W0105041106

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD125G9 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit
Model / Reference
PD125D48
Primary DI / UDI-DI
05407013452836
Basic UDI-DI
5430004263PD125G9
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class B
Market of Registration
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000042647

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
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 05407013452836|5430004263PD125G9 61 fields · synced 24 Oct 2026