Identity
- Trade Name
- Single-Use Uroscope EUDAMED
- Device Name
- Single-Use Uroscope EUDAMED
- Model / Reference
- YS-U-3212 EUDAMEDYS-U-3212H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974413710341 EUDAMED
- Basic UDI-DI
- 697441371S003FG EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Uroscope by Jiangsu Mole Electronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Flexible video ureteroscope, single-use.
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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 | 697441371S003FG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019981
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 08bc5906-030b-49c3-8036-781018ed3978 61 fields · synced Jun 17, 2026