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Shear Wave Quantificational Ultrasound Diagnostic System

by Wuxi Hisky Medical Technologies Co., Ltd. EUDAMED

Active European Union

Ref /Model Plus9000,Plus5000,Plus1000, Plus9000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697167994914RQ Basic UDI-DIDate22 Aug 2025RegisteredStatusActive
European UnionCE/MDR Number697167994914RQ Basic UDI-DIDate22 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Shear Wave Quantificational Ultrasound Diagnostic System
Model / Reference
Plus9000, Plus5000, Plus1000, /
Primary DI / UDI-DI
06971679949140
Basic UDI-DI
697167994914RQ, B-06971679949140
Direct Marketing DI
06971679949140
EMDN Code
Z12040103 Hepatic functionality equipment
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000022547
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • 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