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GenoScreen HPV-HR Plus Screening qPCR Assay

by DiagCor Life Science Limited Hong Kong SAR China EUDAMED

Ref 92042Model 48 tests EMDN W0105041002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04897036920411 Basic UDI-DIDate12 Jun 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  • Withdrawn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 24 Oct 2026

Device Name
GenoScreen HPV-HR Plus Screening qPCR Assay
Model / Reference
48 tests, 92042
Primary DI / UDI-DI
04897036920411
Basic UDI-DI
B-04897036920411
EMDN Code
W0105041002 Screening high-risk hpv - na reagents
Device Class
Class IVD General
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
HK-MF-000045806
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from DiagCor Life Science Limited

See all devices from DiagCor Life Science Limited →

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 04897036920411|B-04897036920411 61 fields · synced 24 Oct 2026