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digene HC2 High-Risk HPV DNA Test

by QIAGEN Sciences LLC

Ref 5197-1330

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04053228010227 Basic UDI-DI 04053228010227UDI-DIDate27 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
5197-1330
Primary DI / UDI-DI
04053228010227
Basic UDI-DI
B-04053228010227
EMDN code
W0105041099 Hpv reagents - other
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000014502
Authorised representative
QIAGEN GmbH DE-AR-000004971

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing

Other properties (8)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains human tissues or cells: No
  • Contains substances of microbial origin: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No