← Back to catalogue
Single use hysteroscope
EUDAMEDClass IIa (EU MDR)
Ref HY-G1Ref HY-H2Ref HY-G2Ref HY-H1
Identity
- Trade Name
- Single use hysteroscope EUDAMED
- Device Name
- Single use hysteroscope EUDAMED
- Model / Reference
- HY-G1 EUDAMEDHY-H2 EUDAMEDHY-G2 EUDAMEDHY-H1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355350246 EUDAMED06971355350666 EUDAMED06971355350253 EUDAMED06971355350659 EUDAMED
- Basic UDI-DI
- 69713553502398R EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria 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
Single use hysteroscope by Shenzhen Besdata 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
- HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · 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
- Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · 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 | 69713553502398R | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED b8924e62-4171-4a73-873c-ebcb83f0c203 61 fields · synced Aug 4, 2026
- EUDAMED 370ccf96-3a2d-4bb4-a0a2-c6824a7502f4 61 fields · synced May 17, 2026
- EUDAMED 3a7191dc-3772-46d9-ac8c-a9899d1c1329 61 fields · synced May 18, 2026
- EUDAMED 44d26d78-10f8-4480-88d5-afb71bf1c5cc 61 fields · synced May 18, 2026