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Metaphase Autostainer

by Shanghai LeChen Biotechnology Co., Ltd. China EUDAMED

Ref 06979232310048Model CP-G-08 EMDN W0202059002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697923231004KW 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  • Withdrawn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
Metaphase Autostainer
Model / Reference
CP-G-08, 06979232310048
Primary DI / UDI-DI
06979232310048
Basic UDI-DI
697923231004KW
EMDN Code
W0202059002 Automated slide stainers
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 (1)

  • EUDAMED 881253bd-353e-41a4-a696-723151cea33c 61 fields · synced 22 Oct 2026