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SeekOne® DD Single Cell TCR Enrichment Kit (Human)

by Beijing SeekGene BioSciences Co., Ltd EUDAMED

Active European Union

Ref 2 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697624137010K2 Basic UDI-DIDate26 May 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
SeekOne™ DD Single Cell TCR Enrichment Kit (Human)
Model / Reference
2 tests
Primary DI / UDI-DI
16976241370107
Basic UDI-DI
697624137010K2
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034144
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties

Show 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