Manufacturer registered with FDA
Remedi Inc.
Chuncheon, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 22020–2024
- Markets registered in
- 922 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Remedi Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Remedi Inc. | 2 clearances | 2020–2024 | Below |
| European Union | EUDAMED | Manufacturer | REMEDI Inc. | 6 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | REMEDI CO., LTD. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | REMEDI Co Ltd | 3 | 2022–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | REMEDI CO., LTDRemedi | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | REMEDIREMEDI CO., LTD. | 2 | 2023–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | REMEDI CO., LTD | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Remedi Co., Ltd | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＲＥＭＥＤＩ Ｉｎｃ． | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Remedi Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | MobileX T-100REMEX-GR100REMEX-T100T-100 | 2019 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | R-Sensor | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Remedi Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Denterprise International, Inc (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Apr 2018 | K180561 | MobileX Portable X-ray System | Denterprise International, Inc | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| REMEDI INC.FDA reg. 3013779985 | Chuncheon Gangwon, South Korea | Complaint file establishment, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060424). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.