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Regulatory approvals
data.go.kr · openFDA15 Korean MFDS device approvals · 2015–2026 / 4 US FDA 510(k) · 2020–2025
- MFDSX-ray system, diagnostic, portable, analogue2026-06-05Product approval · Class 2제인 26-4498 호
- MFDSX-ray system, diagnostic, portable, analogue2025-12-10Product approval · Class 2제인 25-5151 호
- MFDSX-ray system, diagnostic, portable, analogue2025-08-29Product approval · Class 2제인 25-4811 호
- FDAREMEX Xcam62025-07-31
- MFDSMedical image, analog to digital transform, DR, CR2024-12-16Product approval · Class 2수인 24-670 호
- MFDSX-ray system, diagnostic, portable, analogue2024-07-24Product approval · Class 2제인 24-713 호
- FDAREMEX-GR1002024-05-13
- MFDSX-ray system, diagnostic, portable, analogue2021-11-08Product approval · Class 2제인 21-4947 호
- FDARemex KA62021-08-03
- MFDSX-ray system, diagnostic, portable, analogue2020-05-27Product approval · Class 2제인 20-4438 호
- MFDSX-ray system, diagnostic, portable, analogue2020-04-29Product approval · Class 2제인 20-4328 호
- FDAR-Sensor, R-Sensor2020-02-28
Show 7 more
- MFDSX-ray system, diagnostic, portable, analogue2019-09-26Product approval · Class 2제인 19-4809 호
- MFDSStomatoscope, video2019-02-07Product approval · Class 1제신 19-186 호
- MFDSMedical image, analog to digital transform, dental2018-12-14Product approval · Class 2제인 18-5061 호
- MFDSStomatoscope, video2018-02-01Product approval · Class 1제신 18-123 호
- MFDSDental x-ray system, panoramic/tomographic, digital2017-12-19Product approval · Class 2제인 17-4984 호
- MFDSX-ray system, diagnostic, portable, analogue2016-05-10Product approval · Class 2제인 16-4381 호
- MFDSDental x-ray system, general-purpose, intraoral, digital2015-06-09Product approval · Class 2제허 15-904 호
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Companies approved for the same productsMedical Devices
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
Founded in 1992 and KOSDAQ-listed in 2006, VATECH manufactures dental digital X-ray and CT imaging diagnostic devices.
Genoray, founded in 2001 and KOSDAQ-listed in 2018, manufactures medical and dental X-ray imaging diagnostic devices.
KOSDAQ-listed dental medical device company offering the RAYSCAN digital diagnostic system and RAYDENT digital treatment solutions.
KOSDAQ-listed X-ray imaging solution company with a full lineup of medical, dental, veterinary, and industrial X-ray detectors.
Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.
Develops quantitative fluorescence biomarker technology for oral disease diagnostic devices.
Founded in 2001 and KOSDAQ-listed in 2022, Bistos manufactures fetal, neonatal, and patient monitoring medical devices.
KOSDAQ-listed digital diagnostic imaging company providing X-ray systems, detectors, and components.
Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.
Founded in 2009 and KOSDAQ-listed in 2024, SGHealthcare manufactures X-ray, CT, and MRI medical imaging diagnostic devices.
Vieworks, founded in 1999 and KOSDAQ-listed in 2009, develops X-ray detectors and industrial camera imaging solutions.
Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.
Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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