Identity
- Trade Name
- Evolution4K FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- LCD touch screen recording system with HDMI loop through. Software version 1.7.25 FDA UDI
- Model / Reference
- Evo4K130 FDA UDI
- Description
- LCD touch screen recording system with HDMI loop through. Software version 1.7.25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817613021090 FDA UDI
- FDA Product Code
- LMB FDA UDI
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2010 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
No
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 processing unit
Evolution4K by Nds Surgical Imaging, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image processing unit.
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- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
- ILO — ILO electronic GmbH · Class I
- 3NT Video Console — 3nt Medical , Ltd. · Class II
- HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nds Surgical Imaging, Llc.
Sources (1)
- FDA UDI 4543c259-e08a-4249-b7b6-6abb89a85abc 34 fields · synced May 31, 2026