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Sign in to claim this brandSg Healthcare Co, Ltd.
US
Last updated May 23, 2026
What Sg Healthcare Co, Ltd. makes
Sg Healthcare Co, Ltd. manufactures mobile fluoroscopic X-ray systems, including the Jumong General and Jumong Series, as well as the Garion Image-Intensified Fluoroscopic X-Ray System. These devices are designed for real-time imaging in medical procedures, supporting intraoperative and procedural guidance.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) pathway. The portfolio is regulated under US jurisdiction, with no additional international registries specified.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Comlax | CXVW-01 | FDA UDI | Class II | Active |
| Comlax | CXVB-02 | FDA UDI | Class II | Active |
| Comlax | CXVB-01 | FDA UDI | Class II | Active |
| Comlax | CXVW-02 | FDA UDI | Class II | Active |
| Jumong General | K230241 | FDA 510(k) | Class II | Active |
| Jumong Series | K150816 | FDA 510(k) | Class II | Active |
| Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | K243533 | FDA 510(k) | Class II | Active |
| Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | K222080 | EUDAMEDFDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (2)
Establishments registered with the FDA under this company group, matched by name.
- Hlb Co., Ltd. Healthcare Yeondong-myeon Sejong · KR FEI 3024273968
- Sg Healthcare Co Ltd Moga-myeon, Icheon-si Gyeonggi · KR FEI 3009715136