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Sign in to claim this brandSMART MEDICAL SYSTEMS LTD
US
Last updated May 24, 2026
What SMART MEDICAL SYSTEMS LTD makes
The company manufactures flexible fibreoptic colonoscopes, including the G-EYE Colonoscope, designed for endoscopic procedures to examine the interior of the colon. It also produces catheter/overtube balloon inflators, both single-use and reusable, for use in medical imaging and diagnostic procedures. The NaviAid™ SPARKC is another device in its portfolio, likely an advanced imaging aid for colonoscopy.
These devices are classified as Class II under regulatory frameworks, requiring premarket notification (510(k)) submissions or de novo classifications in the US. They are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. 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 Smart Medical Systems Ltd manufacture?
Smart Medical Systems Ltd specializes in flexible fibreoptic colonoscopes, such as the G-EYE Colonoscope, which are used for examining the interior of the colon during endoscopic procedures. Additionally, the company produces catheter/overtube balloon inflators, available in both single-use and reusable versions, for medical imaging and diagnostic applications. Their portfolio also includes advanced imaging aids like the NaviAid™ SPARKC, which likely assists in colonoscopy navigation.
Where is Smart Medical Systems Ltd based?
The company is headquartered in the United States. This location influences its regulatory compliance requirements, particularly under US frameworks like the FDA’s 510(k) and UDI systems.
Which regulatory registries list Smart Medical Systems Ltd’s devices?
The company’s devices are listed in the FDA’s 510(k) registry, which tracks premarket notifications for Class II medical devices, and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance for devices like the G-EYE Colonoscope and NaviAid™ SPARKC.
How are Smart Medical Systems Ltd’s devices classified under regulatory frameworks?
All of Smart Medical Systems Ltd’s devices fall under Class II classification in regulatory systems like the FDA. This classification requires premarket notification (510(k)) submissions or de novo classifications, as Class II devices pose moderate risk and require special controls to ensure safety and effectiveness. Examples include the G-EYE Colonoscope and NaviAid™ SPARKC.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- smartmedsys.com
- —
- —
- [email protected]
- Phone
- +97297444321
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 649905544
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| G-EYE Colonoscope | G-EYE760Z-V/L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH180I | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE38-i10L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEHQ190I | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEQ180AL | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEHQ190L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH190I | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH180AL | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEQ180I | FDA UDI | Class II | Active |
| NaviAid™ SPARKC | SPARKC | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE3890LZi | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEHQ190I | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE3890Li | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH190L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEQ180AI | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE760ZP-V/L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE760S-V/L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEQ180AL | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEHQ190L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH190I | FDA UDI | Class II | Active |
| NaviAid™ AB | AB-R | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE760P-V/L | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYE760R-V/L | FDA UDI | Class II | Active |
| NaviAid™ SPARK | SPARK | EUDAMEDFDA UDI | Class II | Active |
| NaviAid™ ABC | ABC | FDA UDI | Class II | Active |
| NaviAid™ AB | AB-F | FDA UDI | Class II | Active |
| G-EYE Colonoscope | G-EYEH190L | FDA UDI | Class II | Active |
| Naviaid Bge Device, Model 21-001 | K060923 | FDA 510(k) | Class II | Active |
| G-EYE System | K192588 | FDA 510(k) | Class II | Active |
| Naviaid(tm) Bgc Device | K111760 | FDA 510(k) | Class II | Active |
| Naviaid Icvi Device | K101191 | FDA 510(k) | Class II | Active |
| G-EYE System | K202469 | FDA 510(k) | Class II | Active |
| G-EYE System | K220158 | FDA 510(k) | Class II | Active |
| Naviaid Icvi-F, S, B, R Device | K112106 | FDA 510(k) | Class II | Active |
| Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device | K110291 | FDA 510(k) | Class II | Active |
| Naviaid Balloon Guided Colonoscopy (bgc) Device | K102616 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Smart Medical Systems Ltd. Raanana Central · IL FEI 3005261802