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Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

by Hangzhou Dalton BioSciences, Ltd. 3 variants

Ref DH3-072

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697387314DH3SQ Basic UDI-DI 06973873140101UDI-DIDate16 Oct 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
DH3 High-Risk HPV DNA Test
Model / Reference
DH3-072
Primary DI / UDI-DI
06973873140101
Basic UDI-DI
697387314DH3SQ
Direct Marketing DI
06973873140101
EMDN Code
W0105041003 Partial genotyping high-risk hpv - na reagents
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000036196
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Hangzhou Dalton BioSciences, Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No