Identity
- Trade Name
- UE Display FDA UDI
- Generic Name
- Endoscopic video image display unit FDA UDI
- Device Name
- The device is a monitor with a 3 inch LCD screen. The device is to be used in conjunction with various visualization device produced by our company to provide real-time image display. FDA UDI
- Model / Reference
- VL460 FDA UDI
- Description
- The device is a monitor with a 3 inch LCD screen. The device is to be used in conjunction with various visualization device produced by our company to provide real-time image display. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970283483941 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Endoscopic video image display unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video image display unit
UE Display by Zhejiang UE Medical Corp — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp
Sources (2)
- FDA UDI caf25b6f-79b2-4329-acaf-a204ba7e2e23 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026