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HTx Engångshysteroskop
EUDAMEDClass IIa (EU MDR)
Ref HTx60cModel HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L
Identity
- Trade Name
- HTx Engångshysteroskop EUDAMED
- Device Name
- HTx Disposable Hysteroscope EUDAMED
- Model / Reference
- HTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L EUDAMEDHTx60c EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26974880992275 EUDAMED
- Basic UDI-DI
- 697488099ADH001ML EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
HTx Engångshysteroskop by Suzhou AcuVu Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- Hys. 029.15.3020a — Blazejewski MEDI-TECH GmbH · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697488099ADH001ML | Class IIa | Active |
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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 22d6acba-231a-4736-a0d4-eacdbc3480e1 61 fields · synced Jul 29, 2026