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QPursue Dx DNA Sequencing Kit

by Qitan Taike Biotechnology Ltd., Chengdu China EUDAMED

Ref OS002011 EMDN W010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697601989OS002MZ Basic UDI-DIDate13 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
OS002011
Primary DI / UDI-DI
06976019890106
Basic UDI-DI
697601989OS002MZ
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000040515
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Qitan Taike Biotechnology Ltd., Chengdu

See all devices from Qitan Taike Biotechnology Ltd., Chengdu →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 599db9cc-7215-4aaf-8d8e-9f2365f0a532 61 fields · synced 25 Oct 2026