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Clear EVAC
EUDAMEDClass IIa (EU MDR)
Ref PU501-AR (English labelling)Model PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR;
Identity
- Trade Name
- Clear EVAC 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; EUDAMEDPU501-AR (English labelling) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176283907 EUDAMED
- Basic UDI-DI
- 697117628ADE EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Cyprus 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
Clear EVAC by Zhuhai Pusen Medical Technology Co, Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- 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 | 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 06a5f0d6-2727-41a2-a63b-5e98f7530926 61 fields · synced Aug 1, 2026