# Remedi Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 5 (2020–2026): 5 510(k) clearances
- Names in FDA's records: Remedi Co., Ltd. (3); Remedi, Inc. (2)
- Product codes: IZL (3), EHD (1), MUH (1)
- 510(k) review time since 2016: median 54 days, against 58 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Minxray, Inc.: 2 (https://510kreport.com/company/minxray)
- Denterprise International, Inc.: 1 (https://510kreport.com/company/denterprise-international)

## Firms that cite its devices most
- Hdt Co., Ltd.: 1 (https://510kreport.com/company/hdt)
- Prognosys Medical Systems Private Limited: 1 (https://510kreport.com/company/prognosys-medical-systems-private)
- Bontech, Inc.: 1 (https://510kreport.com/company/bontech)

## Its most-cited devices
- K212144: Remex KA6 (2021), cited by 3

## Recent decisions
- K261943: Remex-T (K)100C (Oct 2, 2026)
- K250597: REMEX Xcam6 (Jul 31, 2025)
- K240759: Remex-GR100 (May 13, 2024)
- K212144: Remex KA6 (Aug 3, 2021)
- K200284: R-Sensor, R-Sensor (Feb 28, 2020)

Source page: https://510kreport.com/company/remedi