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Single use flexible ureteroscope
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref UR-F2Model UR-D1,UR-D2,UR-F1,UR-F2
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-F2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355350703 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
Single use flexible ureteroscope by Shenzhen Besdata Technology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240074 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69713553502088E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 3e488ad5-ae3d-451e-acc6-b38e6647ef63 61 fields · synced Jun 19, 2026
- FDA 510(k) K240074 1 fields · synced May 18, 2026