Identity
- Device Name
- Hysteroscope EUDAMED
- Model / Reference
- ZG-2/ZG-3 EUDAMEDX4012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244213614 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
Hysteroscope by Shenyang Shenda Endoscope Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 35880f45-04a2-46cd-8278-fd06fd559f81 61 fields · synced Jun 18, 2026