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Cystoscope
EUDAMEDClass IIa (EU MDR)
Ref N4014Model NP-3Ref J0312AHRef N4200Ref N4019Ref N4102Ref J1370GRef N4022Ref J2330XRef J2300XRef N4201Ref N4102X
Identity
- Device Name
- Cystoscope EUDAMED
- Model / Reference
- NP-3 EUDAMEDN4014 EUDAMEDJ0312AH EUDAMEDN4200 EUDAMEDN4019 EUDAMEDN4102 EUDAMEDJ1370G EUDAMEDN4022 EUDAMEDJ2330X EUDAMEDJ2300X EUDAMEDN4201 EUDAMEDN4102X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244210897 EUDAMED06971244212860 EUDAMED06971244212822 EUDAMED06971244210729 EUDAMED06971244210750 EUDAMED06971244212853 EUDAMED06971244210743 EUDAMED06971244210866 EUDAMED06971244210859 EUDAMED06971244210767 EUDAMED06971244210903 EUDAMED
- Basic UDI-DI
- 697124421PGJ0001D8 EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES 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
Cystoscope 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 | 697124421PGJ0001D8 | 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 (11)
- EUDAMED 169f8a38-98c7-4ea1-9541-aa04badfde0f 61 fields · synced Oct 6, 2026
- EUDAMED fe160e88-79c7-4611-9c5e-e234e1ab49f4 61 fields · synced May 16, 2026
- EUDAMED b91e3418-7866-46dc-a116-bb5a2cf8be3c 61 fields · synced May 17, 2026
- EUDAMED a988b04a-17d5-4152-b213-6f9ecbdd5180 61 fields · synced May 17, 2026
- EUDAMED a858c6e4-f0a5-427e-bb3d-6529ec069dd1 61 fields · synced May 18, 2026
- EUDAMED 7e29972b-78c8-45da-8ecf-985676275d4a 61 fields · synced May 18, 2026
- EUDAMED e98e8aed-6230-49a3-9727-a9773b1e8e8e 61 fields · synced May 18, 2026
- EUDAMED 49770787-99a7-4e26-b7ff-214b6a631673 61 fields · synced May 18, 2026
- EUDAMED 144c3e3e-2244-4bf3-9620-2317760f4331 61 fields · synced May 18, 2026
- EUDAMED 393fbe91-8d7b-4a50-bbfb-4e9a6f6c27bd 61 fields · synced May 19, 2026
- EUDAMED 3efcea4b-a8bf-421b-a7e0-842e3e9bbd22 61 fields · synced May 19, 2026