Data / Medical devices / South Korea / Remedi Inc.
Remedi Inc.: FDA-registered device maker in Chuncheon Gangwon, South Korea, 5 510(k) clearances
Remedi Inc. is registered with the FDA (registration 3013779985) in Chuncheon Gangwon, South Korea. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013779985
- Address
- 2F, 69-14, Sakju-ro 145beon-gil, Chuncheon Gangwon, South Korea, 24232
- Owner or operator
- Remedi Inc. (10060424)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- May 9, 2019
- Registered through
- 2026
- Brand names listed
- ES70, MobileX T-100, R-Sensor, REMEX KA6, REMEX Xcam6, REMEX-GR100, REMEX-T100, T-100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2025 | K250597 | REMEX Xcam6 | IZL | Substantially Equivalent | Remedi, Inc. | accessdata.fda.gov |
| May 13, 2024 | K240759 | REMEX-GR100 | EHD | Substantially Equivalent | Remedi Co., Ltd. | accessdata.fda.gov |
| August 3, 2021 | K212144 | Remex KA6 | IZL | Substantially Equivalent | Remedi Co., Ltd. | accessdata.fda.gov |
| February 28, 2020 | K200284 | R-Sensor, R-Sensor | MUH | Substantially Equivalent | Remedi Co., Ltd. | accessdata.fda.gov |
| April 4, 2018 | K180561 | MobileX Portable X-ray System | EHD | Substantially Equivalent | Denterprise International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Mobile
- All makers of System, X-Ray, Extraoral Source, Digital
Updated July 31, 2025. 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.