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QIAsure Methylation Test

by Self-screen B.V. EUDAMED

Active European Union

Ref 616014

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04053228029083 Basic UDI-DIDate1 Jul 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  • Withdrawn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
QIAsure Methylation Test
Model / Reference
616014
Primary DI / UDI-DI
04053228029083
Basic UDI-DI
B-04053228029083
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000040204

Other devices from Self-screen B.V.

Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No