Single Use Flexible Video Ureteroscope; Single Use Suction Access Ureteroscope; Clear EVAC Single use suction access ureteroscope; Single Use Video Ureteroscope Direct In-Scope Suction;
by Zhuhai Pusen Medical Technology Co., Ltd. 24 variants
Ref PU631A-R (Spanish labelling)Model PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; PU630A-S, PU630A-R, PU631A-S, PU631A-R;
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697117628ADE 06971176283433 | Date18 Nov 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PU3022, PU3022A, PU3033A, PU3033AH, PU400A, PU411A, PU500-AS, PU500-AR, PU501-AS, PU501-AR, PU630A-S, PU630A-R, PU631A-S, PU631A-R, PU631A-R (Spanish labelling)
- Primary DI / UDI-DI
- 06971176283433
- Basic UDI-DI
- 697117628ADE
- EMDN Code
- Z12020713 Ureterorenoscopes
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000009220
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Zhuhai Pusen Medical Technology Co, Ltd
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Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No