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Flexible Digital Uretero-Renoscope
EUDAMEDClass IIa (EU MDR)
Ref UF25Ref UF28Ref UF30
Identity
- Trade Name
- Flexible Digital Uretero-Renoscope EUDAMED
- Device Name
- Flexible Digital Uretero-Renoscope EUDAMED
- Model / Reference
- UF25 EUDAMEDUF28 EUDAMEDUF30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971558930702 EUDAMED06971558930719 EUDAMED06971558930726 EUDAMED
- Basic UDI-DI
- 6971558932UFSP EUDAMED
- Direct Marketing DI
- 06971558930702 EUDAMED06971558930719 EUDAMED06971558930726 EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
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
Flexible Digital 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
- 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
- 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 | 6971558932UFSP | 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 (3)
- EUDAMED 3cd46565-d823-4974-83ad-a3656bf2d026 61 fields · synced Jul 30, 2026
- EUDAMED d9483889-8285-4953-92df-2f24f06bfab7 61 fields · synced May 17, 2026
- EUDAMED f6cc78b1-e3a7-4cd9-a8b5-67f498321ea6 61 fields · synced May 17, 2026