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Digital Pathology Image Processing Analysis Software

by Hangzhou Yipai Intelligent Technology Co., Ltd. China EUDAMED

Ref SW2021070001Model Medipath-K

EMDN V92

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697601860pathana001JB Basic UDI-DIDate17 May 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
数字病理图像处理软件
Model / Reference
Medipath-K, SW2021070001
Primary DI / UDI-DI
06976018602014
Basic UDI-DI
697601860pathana001JB
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000032711
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou Yipai Intelligent Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d87d88f6-14c0-4f1b-8385-abfda1f3e9f2 61 fields · synced 22 Oct 2026