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Uscope
EUDAMEDClass IIa (EU MDR)
Ref Single Use Suction Access Ureteroscope PU411A (Standard Deflection)Model PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR;
Identity
- Trade Name
- Uscope EUDAMED
- Device Name
- Single Use Flexible Video Ureteroscope; Single Use Suction Access Ureteroscope; Clear EVAC Single use suction access ureteroscope; EUDAMED
- Model / Reference
- PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; EUDAMEDSingle Use Suction Access Ureteroscope PU411A (Standard Deflection) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176281019 EUDAMED
- Basic UDI-DI
- 697117628ADE 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
Uscope by Zhuhai Pusen Medical Technology Co, Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697117628ADE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009220
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ba69dee5-3a58-4d72-a44e-91da99a51157 61 fields · synced Jul 10, 2026