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Infivision

by Infivision Medical Imaging Technology Co., Ltd. China EUDAMED

Ref 101001001Model Infivision ET1000

EMDN Z11010801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697441990CHNBJYYEIT10002W Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Electrical Impedance Tomography System
Model / Reference
Infivision ET1000, 101001001
Primary DI / UDI-DI
06974419900005
Basic UDI-DI
697441990CHNBJYYEIT10002W
Direct Marketing DI
06974419900005
EMDN Code
Z11010801 Tomotherapy systems
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000004093
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Infivision Medical Imaging Technology Co., Ltd.

See all devices from Infivision Medical Imaging 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 6ba96aac-10e5-45fc-8ff2-45b2a5563eda 61 fields · synced 24 Oct 2026