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HTx Tek Kullanımlık Histeroskop

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

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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697488099ADH001ML Basic UDI-DI Date28 Nov 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
06974880992943, 26974880992947
Basic UDI-DI
697488099ADH001ML
EMDN Code
Z12020704 Hysteroscopes
Device Class
Class IIa
EU market of registration
Türkiye

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