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Uscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PU3022 (Standard Deflection)Model PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR;
Identity
- Trade Name
- Uscope EUDAMEDFDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- Single Use Flexible Video Ureteroscope; Single Use Suction Access Ureteroscope; Clear EVAC Single use suction access ureteroscope; EUDAMEDThis instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is labeled Standard Deflection. FDA UDI
- Model / Reference
- PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR; EUDAMEDPU3022 (Standard Deflection) EUDAMEDPU3022 FDA UDI
- Description
- This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is labeled Standard Deflection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971176280425 EUDAMEDFDA UDI
- Basic UDI-DI
- 697117628ADE EUDAMED
- 510(k) Number
- K172098 FDA UDI
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Flexible video ureteroscope, single-use
Uscope by Zhuhai Pusen Medical Technology Co, Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697117628ADE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED d4b4ac68-d23e-4c6e-b0a6-2eb037f6392e 61 fields · synced Jun 19, 2026
- FDA UDI 03f588a5-2cc2-4cdd-8971-39e517f01e59 34 fields · synced May 30, 2026