Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVISIONSENSE LTD.
US
Last updated May 30, 2026
What VISIONSENSE LTD. makes
VisionSense Ltd. manufactures endoscopic video camera systems, including models with infrared capabilities, alongside endoscopic video image processing and light source systems. Their portfolio also includes general-purpose surgical microscopes, fibreoptic light cables, endoscopic device remote controls, light source adaptors, and manually-adjusted surgical instrument assist arm systems. These products are designed for use in surgical and diagnostic procedures requiring high-resolution imaging and precise lighting.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These devices are listed under the FDA’s 510(k) and Unique Device Identification (UDI) systems, ensuring compliance with US regulatory requirements. VisionSense Ltd. 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 VisionSense Ltd. manufacture?
VisionSense Ltd. specializes in endoscopic and surgical imaging solutions. Their product range includes endoscopic video cameras—some with infrared capabilities—endoscopic video image processing and light source systems, general-purpose surgical microscopes, fibreoptic light cables, endoscopic remote controls, light source adaptors, and manually-adjusted surgical instrument assist arms. These devices are designed to support high-resolution imaging and precise lighting in surgical and diagnostic procedures.
Where is VisionSense Ltd. based?
VisionSense Ltd. is headquartered in the United States. The company’s location ensures alignment with US regulatory frameworks, including those governing medical device classification and compliance.
Which regulatory registries list VisionSense Ltd.’s devices?
VisionSense Ltd.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance with US medical device regulations, helping to track and monitor devices throughout their lifecycle.
How are VisionSense Ltd.’s devices classified under FDA regulations?
VisionSense Ltd.’s devices fall into either Class I or Class II categories under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- covidien.com
- —
- —
- [email protected]
- Phone
- +1(508)261-8000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 532199478
Catalogue (104)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0052 | FDA UDI | Class II | Active |
| VS3 Pneumatic Arm Tubing Set | VS3-MMS | FDA UDI | Class I | Active |
| VS3 Iridium | 153-0073 | FDA UDI | Class II | Active |
| Vs3-Ne | 174-0001 | FDA UDI | Class II | Active |
| Vs3-Ne | 174-0020 | FDA UDI | Class II | Unknown |
| Vs3-Ir | 174-0012RFB | FDA UDI | Class II | Active |
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| VS3 Iridium | 175-0012RFB | FDA UDI | Class II | Active |
| Vs3-Mms | 174-0010 | FDA UDI | Class I | Unknown |
| Vs3-Ir | 115-0051 | FDA UDI | Class II | Active |
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0072RFB | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0075 | FDA UDI | Class II | Active |
| Vs3-Ne | 153-0002 | FDA UDI | Class II | Active |
| Vs3-Ir | 560-6453 | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0054 | FDA UDI | Class II | Active |
| Vs3-Ir | 145-0011 | FDA UDI | Class II | Active |
| Vs3-Ir | 161-0001RFB | FDA UDI | Class II | Active |
| Vs3-Ir | 174-0012 | FDA UDI | Class II | Active |
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| Vs3-Ne | 153-0003 | FDA UDI | Class II | Active |
| Vs3-Ir | 161-0001 | FDA UDI | Class II | Active |
| Vs3-Ir | 175-0051 | FDA UDI | Class II | Active |
| Lamp Module For LS300 Xenon Lightsource | VS3-IR | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0052RFB | FDA UDI | Class II | Active |
| Vs3-Ir | 115-0051RFB | FDA UDI | Class II | Active |
| Twin gas bottle holder | VS3-IR | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0074 | FDA UDI | Class II | Active |
| Vs3-Ir | 465-0011 | FDA UDI | Class II | Active |
| Vs3-Ir | 465-0011 | FDA UDI | Class II | Active |
| Vs3-Ir | 153-0073 | FDA UDI | Class II | Active |
| Power Cord for VS3 Cart - Italy | VS3 | FDA UDI | Class II | Active |
| Vs3-Ir | 175-0051 | FDA UDI | Class II | Active |
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| Vs3-Ir | 161-0001 | FDA UDI | Class II | Active |
| Vs3-Ne | 443-0001 | FDA UDI | Class II | Active |
| VS3 Iridium - Y Laser Light Cable for Fluorescence | VS3-IR | FDA UDI | Class II | Active |
| Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR) | VS3-IR | FDA UDI | Class II | Active |
| Power Cord for VS3 Cart - Argentina | VS3 | FDA UDI | Class II | Active |
| Power Cord for VS3 Cart - Brazil | VS3 | FDA UDI | Class II | Active |
| Trans-anal Introducer | K171208 | FDA 510(k) | Class II | Active |
| Vs-Visionsense Stereoscopic Vision System | K073279 | FDA 510(k) | Class II | Active |
| VS3 Iridium Sytem | K210265 | FDA 510(k) | Class II | Active |
| Visionsense Stereoscopic Vision System (vs System) | K082667 | FDA 510(k) | Class II | Active |
| VS3-IR system | K152204 | FDA 510(k) | Class II | Active |
| Vs3 Stereoscopic High Definition Vision System | K131434 | FDA 510(k) | Class II | Active |
| VS3-IR-MMS System | K150018 | FDA 510(k) | Class II | Active |
| Vs3 Stereoscopic High Definition Vision System | K141002 | FDA 510(k) | Class II | Active |
| Visionsense Stereoscopic Vision System | K082355 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.