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Eview
EUDAMEDFDA UDIClass I (EU MDR)
Ref HD Medical Video Endoscope Image Processor PV300 (English labelling)Model PV220; PV300, PVX800
Identity
- Trade Name
- Eview EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Medical Video Endoscope Image Processor; HD Medical Video Endoscope Image Processor EUDAMEDThis instrument has been designed to be used to process signals from a video endoscope and convert it to a signal that can be displayed on a monitor. FDA UDI
- Model / Reference
- PV220; PV300, PVX800 EUDAMEDHD Medical Video Endoscope Image Processor PV300 (English labelling) EUDAMEDPV300 FDA UDI
- Description
- This instrument has been designed to be used to process signals from a video endoscope and convert it to a signal that can be displayed on a monitor. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971176280241 EUDAMEDFDA UDI
- Basic UDI-DI
- 697117628EDN EUDAMED
- Direct Marketing DI
- 06971176280241 EUDAMED
- 510(k) Number
- K222602 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Eview by Zhuhai Pusen Medical Technology Co, Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697117628EDN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9df7c1a7-9eb8-4b90-9983-87e4e49475fa 61 fields · synced Jul 14, 2026
- FDA UDI 17d26506-5f42-48f7-869c-6a785efca332 34 fields · synced May 22, 2026