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DermaGenius® 2.0 Complete Multiplex real-time PCR kit

by PathoNostics B.V. EUDAMED

Active European Union

Ref PN-401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number87193267509PN-401EQ Basic UDI-DIDate27 Mar 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
PN-401
Primary DI / UDI-DI
08719326750934
Basic UDI-DI
87193267509PN-401EQ
Direct Marketing DI
08719326750934
EMDN Code
W0105060402 Candida albicans - na reagents
Device Class
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002705

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Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No