Manufacturer registered with FDA
Digimed Co., Ltd.
Seoul, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 62008–2023
- Markets registered in
- 8138 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name Digimed Co., Ltd. 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 | Digimed Co., Ltd. | 6 clearances | 2008–2023 | Below |
| Argentina | ANMAT | Registration holder | DIGIMED S.A. | 91 | — | Pure Global AI |
| India | CDSCO | Registration holder | Digimed | 33 | 2023–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DigiMed Co., Ltd.DIGIMED CORPORATION · DigiMed Corporation · +1 | 6 | 2009–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DIGIMED Co., Ltd. | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DIGIMED CO., Ltd | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DIGIMED Co., Ltd. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Digimed Co Ltd | 1 | 2024–2024 | 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 Digimed Co., Ltd. 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 | Dhx-70hDIOX-602Hybrid C70HYBRID ProHYBRID S70MiniX-SMiniX-VPROXxm-liteXTG 1 moreXtg-70h | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Digimed Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Mar 2023 | K221587 | DHX-70H, XTG-70H | EHD Extraoral with Timer X-Ray Unit |
| 1 Sep 2022 | K220579 | Hybrid C70 | EHD Extraoral with Timer X-Ray Unit |
| 22 Apr 2022 | K220574 | HYBRID S70 | EHD Extraoral with Timer X-Ray Unit |
| 10 Aug 2018 | K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | EHD Extraoral with Timer X-Ray Unit |
| 8 Apr 2011 | K103600 | PORTABLE X-RAY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 26 Sep 2008 | K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIGIMED CO., LTDFDA reg. 3007933232 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034335). 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.