Identity
- Device Name
- Resectoscope EUDAMED
- Model / Reference
- QD-2 EUDAMEDJ0330H EUDAMEDJ0312A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244212150 EUDAMED06971244212198 EUDAMED
- Basic UDI-DI
- 697124421DQJ0001AW EUDAMED
- EMDN Code
- Z12020707 RESECTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Resectoscope 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 | 697124421DQJ0001AW | 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 (2)
- EUDAMED 6b57a6d2-cf82-47a3-b5cd-467fec74d31c 61 fields · synced Oct 6, 2026
- EUDAMED 3ff2f21e-e381-45f5-ab48-50e74813acee 61 fields · synced May 19, 2026