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HTx Disposable Hysteroscope

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

Ref /Model HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L

EMDN Z12020704

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697488099ADH001ML Basic UDI-DIDate28 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L, /
Primary DI / UDI-DI
26974880991803
Basic UDI-DI
697488099ADH001ML
EMDN Code
Z12020704 Hysteroscopes
Device Class
Class IIa
Market of Registration
France

Manufacturer details

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

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

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 74c743a6-ecda-4b3e-82db-1f4575742f0e 61 fields · synced 22 Oct 2026