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Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)

by RocGene (Xuzhou) Technology Limited China EUDAMED

Ref 10210109BModel 50 tests/kit EMDN W0105070201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974795550597 Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)
Model / Reference
50 tests/kit, 10210109B
Primary DI / UDI-DI
06974795550597
Basic UDI-DI
B-06974795550597
EMDN Code
W0105070201 Gram+ - gram- - fungi - multiplex na reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000024511
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
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 81b41642-ac3d-4ba8-bb72-71b2d84bd615 61 fields · synced 25 Oct 2026