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Human Leukocyte Antigen (HLA) Genotyping Kit (Single-Molecule Nanopore Strand Sequencing)

by Qitan Taike Biotechnology Ltd., Chengdu EUDAMED

Active European Union

Ref OS006011

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976019890168 Basic UDI-DIDate26 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
OS006011
Primary DI / UDI-DI
06976019890168
Basic UDI-DI
B-06976019890168
EMDN Code
W01030499 Tissue typing reagents - other
Device Class
Class IVD General
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

  • Reagent
  • Professional Testing

Other properties (8)

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