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Sign in to claim this brandGemss Medical Systems Co., Ltd.
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- gemss-medical.com
- —
- —
- [email protected]
- Phone
- +82317462211
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689163897
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Image-intensified fluoroscopic x-ray system, mobile | KMC-650 | FDA UDI | Class II | Active |
| System, X-Ray, Stationary | TITAN 11 | FDA UDI | Class II | Active |
| System, X-Ray, Fluoroscopic, Image-Intensified | KMC-950 | FDA UDI | Class II | Active |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | SPINEL 3G | FDA UDI | Class II | Active |
| Interventional Fluoroscopic Mobile X-ray System | SPINEL 12HD | FDA UDI | Class II | Active |
| SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System | K163140 | FDA 510(k) | Class II | Active |
| GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | K160065 | FDA 510(k) | Class II | Active |
| Titan 11 | K133695 | FDA 510(k) | Class II | Active |
| Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray System | K132289 | FDA 510(k) | Class II | Active |
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