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Μητροσκόπιο μίας χρήσης HTx

by Suzhou AcuVu Medical Technology Co., Ltd. 8 variants

Ref HTx60cModel HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L

Active European Union

CE MDR

Valid until

1 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6168345CE01 Date11 Aug 2026IssuedStatusActive expires 1 Nov 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6168345CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    11 Aug 2026
    Expires
    1 Nov 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
HTx Disposable Hysteroscope
Model / Reference
HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L
Primary DI / UDI-DI
06974880992790, 26974880992794
Basic UDI-DI
697488099ADH001ML
EMDN Code
Z12020704 Hysteroscopes
Device Class
Class IIa
EU market of registration
Greece

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

  • 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