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Cell-free DNA Library Preparation Kit

by Cygnus Biosciences (Beijing) Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref G-211-185-101

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697499685005TX Basic UDI-DIDate1 Jul 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Cell-free DNA Library Preparation Kit
Model / Reference
G-211-185-101
Primary DI / UDI-DI
06974996850366
Basic UDI-DI
697499685005TX
Direct Marketing DI
06974996850366
EMDN Code
W010699 Genetic tests - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000027934
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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