Skip to content

Poly Diagnostics Dientamoeba fragilis, RNase P Real-Time PCR kit

by Poly Diagnostics EUDAMED

Active European Union

Ref PD160D24

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD160GB 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  • Withdrawn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 Dientamoeba fragilis, RNase P Real-Time PCR kit
Model / Reference
PD160D24
Primary DI / UDI-DI
05407013453833
Basic UDI-DI
5430004263PD160GB
EMDN Code
W0105070504 Gastrointestinal infections - multiplex 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

Show 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