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HTx image processing system

by Suzhou AcuVu Medical Technology Co., Ltd. China EUDAMED

Ref /Model HTx1000, HTx2000

EMDN Z12020406

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697488099IPS002XF Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

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
Image processing system
Model / Reference
HTx1000, HTx2000, /
Primary DI / UDI-DI
06974880992929
Basic UDI-DI
697488099IPS002XF
EMDN Code
Z12020406 Video processors
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000038586
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Suzhou AcuVu medical technology Co., Ltd.

See all devices from Suzhou AcuVu medical 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 aff77323-bf76-4f99-a9ae-8d7ee9976e9f 61 fields · synced 22 Oct 2026