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Pulmonary nodules CT imaging aided detection software

by Hangzhou Deepwise & League of PHD Technology Co., Ltd. China EUDAMED

Ref Dr. Wise PNAB EMDN Z11030692

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697421859000KV Basic UDI-DIDate19 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Pulmonary nodules CT imaging aided detection software
Model / Reference
Dr. Wise PNAB
Primary DI / UDI-DI
06974218590001
Basic UDI-DI
697421859000KV
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000012939
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou Deepwise & League of PHD Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 37f671aa-8bc3-4f61-b524-ee6e09049490 61 fields · synced 24 Oct 2026