Identity
- Device Name
- Hysteroscope EUDAMED
- Model / Reference
- ZG-2/ZG-3 EUDAMEDX4017S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244213638 EUDAMED
- Basic UDI-DI
- 697124421GQJ0002CK EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Hysteroscope by Shenyang Shenda Endoscope Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rigid video hysteroscope.
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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 | 697124421GQJ0002CK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenyang Shenda Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030478
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 473d29aa-0b3d-4925-a2bb-08bb32aacccd 61 fields · synced Jun 18, 2026