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Histeroscópio Descartável HTx

EUDAMED

Class IIa (EU MDR)

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

by Suzhou AcuVu Medical Technology Co., Ltd.

Identity

Trade Name
Histeroscópio Descartável HTx EUDAMED
Device Name
HTx Disposable Hysteroscope EUDAMED
Model / Reference
HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L EUDAMED
HTx40-L EUDAMED

Identifiers

Primary DI / UDI-DI
26974880992855 EUDAMED
Basic UDI-DI
697488099ADH001ML EUDAMED
EMDN Code
Z12020704 HYSTEROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Portugal EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Rigid video hysteroscope

The Histeroscópio Descartável HTx is a class IIa medical device used for visualizing the female reproductive organs. It features advanced imaging capabilities, ensuring accurate diagnoses and effective treatment. The device's sterile design and disposable option provide an additional layer of safety, making it suitable for high-risk patients.

Similar devices

Also classified as Rigid video hysteroscope.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Suzhou AcuVu Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000038586
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (1)

  • EUDAMED 4d6a7a8d-4bf2-4667-bb87-22189fb24edf 61 fields · synced Oct 6, 2026