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Single-Use Uroscope
EUDAMEDClass IIa (EU MDR)
Ref YS-U-2512HModel YS-U-3212Ref YS-U-2512
Identity
- Trade Name
- Single-Use Uroscope EUDAMED
- Device Name
- Single-Use Uroscope EUDAMED
- Model / Reference
- YS-U-3212 EUDAMEDYS-U-2512H EUDAMEDYS-U-2512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974413710365 EUDAMED06974413710358 EUDAMED06974413710259 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
Similar devices
Also classified as Flexible video ureteroscope, single-use.
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- 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 | 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 (3)
- EUDAMED 3c03a82f-0cfb-418b-a754-bed93af3fd45 61 fields · synced Jul 23, 2026
- EUDAMED 1b7b7bc9-957b-45de-8ef3-6f7a717da090 61 fields · synced May 18, 2026
- EUDAMED 39e0b662-3d21-4fca-99e0-4b2390a4c3df 61 fields · synced May 18, 2026