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GenoScreen HPV-HR Screening qPCR Assay (Lyophilized)

by DiagCor Life Science Limited EUDAMED

Active European Union

Ref 92041Model 48 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04897036920404 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  • Withdrawn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

Device Name
GenoScreen HPV-HR Screening qPCR Assay (Lyophilized)
Model / Reference
48 tests, 92041
Primary DI / UDI-DI
04897036920404
Basic UDI-DI
B-04897036920404
EMDN Code
W0105041003 Partial genotyping 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

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Properties

Show properties
  • 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