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Sign in to claim this brandIsent Tech & Trading Company, Ltd.
US
Last updated May 23, 2026
What Isent Tech & Trading Company, Ltd. makes
Isent Tech & Trading Company, Ltd. manufactures the ISEN-Goggles with Data Viewer, a device designed for visual data display and monitoring, likely integrated with augmented or virtual reality capabilities for real-time information overlay.
The ISEN-Goggles with Data Viewer is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Isent Tech & Trading Company, Ltd. manufacture?
Isent Tech & Trading Company, Ltd. manufactures the ISEN-Goggles with Data Viewer, a device intended for visual data display and monitoring. This device appears to integrate augmented or virtual reality features to overlay real-time information, likely supporting applications in medical or clinical environments where visual data interpretation is critical.
Where is Isent Tech & Trading Company, Ltd. based?
Isent Tech & Trading Company, Ltd. is based in the United States. The company’s location is relevant for understanding regulatory frameworks and compliance requirements that may apply to its devices.
How are the devices manufactured by Isent Tech & Trading Company, Ltd. classified in the US?
The ISEN-Goggles with Data Viewer, the primary device produced by Isent Tech & Trading Company, Ltd., is classified as a Class II medical device in the United States. This classification typically indicates moderate risk, requiring compliance with specific regulatory controls to ensure safety and effectiveness before market introduction.
Which regulatory registries or pathways list the devices made by Isent Tech & Trading Company, Ltd.?
The ISEN-Goggles with Data Viewer is listed under the FDA’s 510(k) pathway. This pathway is used for demonstrating substantial equivalence to a legally marketed predicate device, ensuring that the new device meets the same safety and performance standards as its predecessor.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ISEN-Goggles | V06 | FDA UDI | Class II | Active |
| ISEN-Goggles | K152727 | FDA 510(k) | Class II | Active |
| ISEN-Goggles with Data Viewer | K163270 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Isen Tech.&Trading Co., Ltd. Beijing · CN FEI 3011522961