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MedSharp Karyo

by ZKYH AImed Technology （Guangxi） Co., LTD. China EUDAMED

Ref Med-Sharp Karyo EMDN W02020501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697889490MKAK Basic UDI-DIDate31 Aug 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  • Withdrawn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
MedSharp Karyo
Model / Reference
Med-Sharp Karyo
Primary DI / UDI-DI
06978894900123
Basic UDI-DI
697889490MKAK
EMDN Code
W02020501 Histological samples analysers
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047063
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from ZKYH AImed Technology （Guangxi） Co., LTD.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 7cac30ec-5c5b-448d-868f-d41c73c5bdbf 61 fields · synced 22 Oct 2026