← Back to catalogue
Single use flexible ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref UR-D2Model UR-D1,UR-D2,UR-F1,UR-F2Ref UR-F1Ref UR-D1
Identity
- Trade Name
- Single use flexible ureteroscope EUDAMED
- Device Name
- Single use flexible ureteroscope EUDAMED
- Model / Reference
- UR-D1,UR-D2,UR-F1,UR-F2 EUDAMEDUR-D2 EUDAMEDUR-F1 EUDAMEDUR-D1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355350680 EUDAMED06971355350697 EUDAMED06971355350673 EUDAMED
- Basic UDI-DI
- 69713553502088E EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 ureteroscope by Shenzhen Besdata Technology 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 | 69713553502088E | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED cfeee855-ac55-4c6b-bfd9-217ffe815115 61 fields · synced Jul 20, 2026
- EUDAMED a6565dd2-4f29-4b84-ad8e-3dea51b67fa9 61 fields · synced May 18, 2026
- EUDAMED 5f14e53f-bed5-419e-8e3d-78992e32f1ae 61 fields · synced May 19, 2026