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Kuohai Technology

by Xiaogan Kuohai Medical Technology Co., Ltd. China EUDAMED

Ref KCT-05Model KCT-05 KCT-06 KCT-07 KCT-08 KCT-10 KCT-11 KCT-12 KCT-13 KCT-14 KCT-15 KCT-16 KCT-17 KCT-18 KCT-19 KCT-20

EMDN W02069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697718507KHLBCPTZ Basic UDI-DIDate11 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Liquid Based Cytology Processor
Model / Reference
KCT-05 KCT-06 KCT-07 KCT-08 KCT-10 KCT-11 KCT-12 KCT-13 KCT-14 KCT-15 KCT-16 KCT-17 KCT-18 KCT-19 KCT-20, KCT-05
Primary DI / UDI-DI
06977185070590
Basic UDI-DI
697718507KHLBCPTZ
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000040038
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Xiaogan Kuohai Medical Technology Co., Ltd.

See all devices from Xiaogan Kuohai Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (7)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED b3609308-c8ae-4aab-bf62-03f37075c71e 61 fields · synced 25 Oct 2026