Data / Medical devices / System, X-Ray, Stationary / South Korea
FDA-registered makers of System, X-Ray, Stationary in South Korea: 12 establishments
12 establishments in South Korea are registered with the FDA to make System, X-Ray, Stationary (product code KPR). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, X-Ray, Stationary
- Product code
- KPR
- Country
- South Korea
Makers of System, X-Ray, Stationary in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Samsung Electronics Co., Ltd. | Seoul, South Korea | Complaint file establishment, Manufacturer, Specification developer | 8 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 8 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | Complaint file establishment, Specification developer | 5 | January 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | Manufacturer | 5 | January 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| DK Medical Systems Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 3 | April 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| JPI Healthcare Co., Ltd | Seoul, South Korea | Manufacturer | 3 | June 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| SG Healthcare Co Ltd | Moga-myeon, Icheon-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 3 | February 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | September 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Gemss Healthcare Co., Ltd. | Gyeonggi, South Korea | Manufacturer | 2 | November 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Daeil Precision Industry Co.,ltd | Geumcheongu Seoul, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drtech Corporation | Seongnam-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&abyz | Yongin-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.