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

by Poly Diagnostics 4 variants

Ref PD116L96

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430004263PD116G8 Basic UDI-DI 05430004263876UDI-DIDate21 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit
Model / Reference
PD116L96
Primary DI / UDI-DI
05430004263876
Basic UDI-DI
5430004263PD116G8
EMDN Code
W0105040521 Parechovirus - na reagents
Device Class
Class B
EU 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