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Single-Use Flexible Cystoscope
EUDAMEDClass IIa (EU MDR)
Ref UNEN-BD50DModel UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E
Identity
- Device Name
- Single-Use Flexible Cystoscope EUDAMED
- Model / Reference
- UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E EUDAMEDUNEN-BD50D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955797773542 EUDAMED
- Basic UDI-DI
- 69557977UNEN003DG EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 Cystoscope by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
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- 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 | 69557977UNEN003DG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimicro Medical Systems (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000014590
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 43acb799-caf9-4e85-95c4-3d559b8a50ab 61 fields · synced Jul 26, 2026