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Single-use Flexible Video Ureterorenoscope
EUDAMEDClass IIa (EU MDR)
Ref DURS1-121PRModel DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRSRef DURS1-120PRRef DURS1-120PSRef DURS1-121PRef DURS1-121PS
Identity
- Trade Name
- Single-use Flexible Video Ureterorenoscope EUDAMED
- Device Name
- Single-use Flexible Video Ureterorenoscope EUDAMED
- Model / Reference
- DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRS EUDAMEDDURS1-121PR EUDAMEDDURS1-120PR EUDAMEDDURS1-120PS EUDAMEDDURS1-121P EUDAMEDDURS1-121PS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235401113 EUDAMED06974235401199 EUDAMED06974235401182 EUDAMED06974235401090 EUDAMED06974235401106 EUDAMED
- Basic UDI-DI
- 697423540DURSN4 EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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 Video Ureterorenoscope by Himaging Technology (Shanghai) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- 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
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 | 697423540DURSN4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Himaging Technology (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000028002
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED e12bdc9b-6827-4ad1-b513-8b568d77938c 61 fields · synced Aug 5, 2026
- EUDAMED b96875b4-617b-4bde-8d67-7def7c6123a8 61 fields · synced May 16, 2026
- EUDAMED 4151ee08-9941-4dce-9333-97349e1afd5f 61 fields · synced May 17, 2026
- EUDAMED fc1b4fc0-642b-4454-b677-a6d551979789 61 fields · synced May 18, 2026
- EUDAMED 63acfda7-1888-4a7b-a1d6-61713a430de6 61 fields · synced May 19, 2026