# REMEDI Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. REMEDI Inc. is a medical device manufacturer based in South Korea, with 5 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (EU Class IIb; FDA Class II) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/remedi-inc>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000026327
- FDA FEI: 3013779985

## Figures

- Devices: 5
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 3, FDA 510(k) 2, FDA GUDID 1
- Device classes: EU Class IIb 3, FDA Class II 2
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 3 devices

## Sites and related companies

- Authorised representative: [JaviTech e.K.](https://devicerts.com/representatives/javitech-ek-de-ar-000005875) (Germany)

## Devices

The first 5 of 5, in the order of the canonical page, which lists them all.

- [Remex-T(K)100C](https://devicerts.com/devices/remex-t-k-100c-izl) · ref K261943 · Class II · 510(k) · status: Active · decision 2026-10-02
- [REMEX Xcam6](https://devicerts.com/devices/remex-xcam6-izl) · ref K250597 · Class II · 510(k) · status: Active · decision 2025-07-31
- [Remex-K100](https://devicerts.com/devices/remex-k100-rem-ifu-t-k-100) · ref REM-IFU-T(K)100 · Class IIb · EUDAMED · status: Active
- [Stationary Anode X-ray tube](https://devicerts.com/devices/stationary-anode-x-ray-tube-rem-ifu-rmt08) · ref REM-IFU-RMT08 · Class IIb · EUDAMED · status: Active
- [Portable X-ray equipment](https://devicerts.com/devices/portable-x-ray-equipment-rem-ifu-t-k-100-inst) · ref REM-IFU-T(K)100\_Instruction For Use · Class IIb · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: REMEDI Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/remedi-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/remedi-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/remedi-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.