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Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit

by Poly Diagnostics EUDAMED

Active European Union

Ref PD116D48

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD116G8 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit
Model / Reference
PD116D48
Primary DI / UDI-DI
05407013452591
Basic UDI-DI
5430004263PD116G8
EMDN Code
W0105040521 Parechovirus - na reagents
Device Class
Class B
Market of Registration
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000042647

Other devices from Poly Diagnostics

See all devices from Poly Diagnostics →

Properties

  • 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