# DigiMed Co., Ltd.

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

- Canonical page: <https://devicerts.com/manufacturers/digimed-co-ltd>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000016608
- DUNS: 688265810

## Figures

- Devices: 15
- EU certificates: 1
- 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: FDA GUDID 11, EUDAMED 7, FDA 510(k) 4
- Device classes: FDA Class II 13, EU Class IIb 2
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 2 devices

## Sites and related companies

- Authorised representative: [KTR Europe GmbH](https://devicerts.com/representatives/ktr-europe-gmbh-de-ar-000005685) (Germany)

## Devices

The first 15 of 15, in the order of the canonical page, which lists them all.

- [Xtg 1](https://devicerts.com/devices/xtg-1) · Class II · GUDID · status: Active
- [Xtg V 1](https://devicerts.com/devices/xtg-v-1) · Class II · GUDID · status: Active
- [XTG PRO 70 HYBRID Pro](https://devicerts.com/devices/xtg-pro-70-hybrid-pro) · Class II · EUDAMED, GUDID · status: Active
- [Diox-602 1](https://devicerts.com/devices/diox-602-ddc-03) · Class II · EUDAMED, GUDID · status: Active · open recall
- [Biox 1](https://devicerts.com/devices/biox-1) · Class II · GUDID · status: Listed
- [Hybrid S70 1](https://devicerts.com/devices/hybrid-s70-1) · Class II · EUDAMED, GUDID · status: Active
- [MiniX-V 1](https://devicerts.com/devices/minix-v-dmc-07) · Class II · GUDID · status: Listed
- [Dhx-70H 1](https://devicerts.com/devices/dhx-70h-1) · Class II · EUDAMED, GUDID · status: Active
- [xm-lite HYBRID C70](https://devicerts.com/devices/xm-lite-hybrid-c70) · Class II · EUDAMED, GUDID · status: Active
- [Dmc-04](https://devicerts.com/devices/prox-dmc-04) · Class IIb · EUDAMED, GUDID · status: Active
- [Hybrid S70](https://devicerts.com/devices/hybrid-s70-ehd) · ref K220574 · Class II · 510(k) · status: Active · decision 2022-04-22
- [Dhx-70H, Xtg-70H](https://devicerts.com/devices/dhx-70h-xtg-70h-ehd) · ref K221587 · Class II · 510(k) · status: Active · decision 2023-03-03
- [Portable X-ray System (Model: MiniX-V, Mini X-S)](https://devicerts.com/devices/portable-x-ray-system-model-minix-v-mini-x-s-ehd) · ref K181891 · Class II · 510(k) · status: Active · decision 2018-08-10
- [Hybrid C70](https://devicerts.com/devices/hybrid-c70-ehd) · ref K220579 · Class II · 510(k) · status: Active · decision 2022-09-01
- [Dmc-07](https://devicerts.com/devices/minix-s-dmc-07) · Class IIb · EUDAMED, GUDID · status: Active

## EU certificates

- C533314 · Quality management system · MDR · notified body DNV Product Assurance AS · issued 2024-06-21 · expires 2029-06-21 · status: issued

## Source and citation

- Cite as: DigiMed Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/digimed-co-ltd (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [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/digimed-co-ltd.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/digimed-co-ltd
- 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.