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QNome-3841 Nanopore Sequencer

by Qitan Taike Biotechnology Ltd., Chengdu China EUDAMED

Ref OY001001 EMDN W02050115

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697601989OY001P9 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  • Withdrawn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 22 Oct 2026

Model / Reference
OY001001
Primary DI / UDI-DI
06976019890038
Basic UDI-DI
697601989OY001P9
Direct Marketing DI
06976019890038
EMDN Code
W02050115 DNA synthesizers
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
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 15ae9047-ec95-44c3-8878-e071c69ea424 61 fields · synced 22 Oct 2026