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

by Poly Diagnostics Luxembourg EUDAMED

Ref PD160L96

EMDN W0105070504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD160GB 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 Dientamoeba fragilis, RNase P Real-Time PCR kit
Model / Reference
PD160L96
Primary DI / UDI-DI
05430005087259
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

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 05430005087259|5430004263PD160GB 61 fields · synced 24 Oct 2026