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DermaGenius® Screening multiplex real-time PCR kit

by PathoNostics B.V. Netherlands EUDAMED

Ref PN-304 EMDN W0105060499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number87193274980PN-304FU Basic UDI-DIDate2 Sep 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
PN-304
Primary DI / UDI-DI
08719327498057
Basic UDI-DI
87193274980PN-304FU
Direct Marketing DI
08719327498057
EMDN Code
W0105060499 Mycology na reagents - other
Device Class
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002705

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See all devices from PathoNostics B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED bbcc653a-e52b-4b35-9e69-741dcb8c97ac 61 fields · synced 24 Oct 2026