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Cell Autoharvester

by Shanghai LeChen Biotechnology Co., Ltd. China EUDAMED

Ref 06979232310017, 06979232310024Model CP-II-32, CP-II EMDN W02050104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697923231001KQ Basic UDI-DIDate21 Jan 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Cell Autoharvester
Model / Reference
CP-II-32, 06979232310017, CP-II, 06979232310024
Primary DI / UDI-DI
06979232310017, 06979232310024
Basic UDI-DI
697923231001KQ, 697923231002KS
EMDN Code
W02050104 Karyotype processing automated systems
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051606
Authorised representative
Everbiz GmbH AT-AR-000035279

Other devices from Shanghai LeChen Biotechnology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 212c146d-48e3-4d4a-92f8-e91555516bd5 61 fields · synced 22 Oct 2026
  • EUDAMED 06979232310024|697923231002KS 61 fields · synced 18 May 2026