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Single-use Flexible Uretero-Renoscope
EUDAMEDClass IIa (EU MDR)
Ref DUC-M30Model DUC-M10, DUC-M20, DUC-M30, DUC-N10, DUC-N30Ref SUF30Model SUF25,SUF28, SUF30Ref SUF25Ref DUC-M10Ref SUF28
Identity
- Device Name
- Single-use Flexible Uretero-Renoscope EUDAMED
- Model / Reference
- DUC-M10, DUC-M20, DUC-M30, DUC-N10, DUC-N30 EUDAMEDDUC-M30 EUDAMEDSUF25,SUF28, SUF30 EUDAMEDSUF30 EUDAMEDSUF25 EUDAMEDDUC-M10 EUDAMEDSUF28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971558931402 EUDAMED06971558931105 EUDAMED06971558931129 EUDAMED06971558931389 EUDAMED06971558931112 EUDAMED
- Basic UDI-DI
- 697155893DUCV6 EUDAMED697155893SUFXP EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Flexible video ureteroscope, single-use
Single-use Flexible Uretero-Renoscope by Zhuhai Vision Medical Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Ureterorenoscope — Innoview GmbH · Class IIa
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- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
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 | 697155893DUCV6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Vision Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000016785
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 83d75059-5d0e-46c7-b456-b2b15924f120 61 fields · synced Jul 20, 2026
- EUDAMED 999caf1b-c710-48a8-b584-c55219b71262 61 fields · synced May 18, 2026
- EUDAMED 94b2e3c1-00ce-404d-bf38-7a8f43e0106e 61 fields · synced May 18, 2026
- EUDAMED 836e83a5-be6d-4e1e-a9b5-48e772bc2de7 61 fields · synced May 18, 2026
- EUDAMED e61038ad-f38e-4a6e-8aeb-b903ce32fe9e 61 fields · synced May 19, 2026