{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "DigiMed Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/digimed-co-ltd (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/digimed-co-ltd",
    "json_url": "https://devicerts.com/manufacturers/digimed-co-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/digimed-co-ltd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "manufacturer": {
    "name": "DigiMed Co., Ltd.",
    "url": "https://devicerts.com/manufacturers/digimed-co-ltd",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "South Korea",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000016608"
      },
      {
        "label": "DUNS",
        "value": "688265810"
      }
    ],
    "summary": "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.",
    "noindex": false
  },
  "counts": {
    "devices": 15,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 11
      },
      {
        "registry": "EUDAMED",
        "devices": 7
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 13
      },
      {
        "class": "EU Class IIb",
        "devices": 2
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 2
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "KTR Europe GmbH",
        "url": "https://devicerts.com/representatives/ktr-europe-gmbh-de-ar-000005685",
        "country": "Germany"
      }
    ]
  },
  "devices": {
    "shown": 15,
    "total": 15,
    "all_devices_url": "https://devicerts.com/manufacturers/digimed-co-ltd",
    "items": [
      {
        "name": "Xtg 1",
        "url": "https://devicerts.com/devices/xtg-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Xtg V 1",
        "url": "https://devicerts.com/devices/xtg-v-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "XTG PRO 70 HYBRID Pro",
        "url": "https://devicerts.com/devices/xtg-pro-70-hybrid-pro",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Diox-602 1",
        "url": "https://devicerts.com/devices/diox-602-ddc-03",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Biox 1",
        "url": "https://devicerts.com/devices/biox-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hybrid S70 1",
        "url": "https://devicerts.com/devices/hybrid-s70-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "MiniX-V 1",
        "url": "https://devicerts.com/devices/minix-v-dmc-07",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dhx-70H 1",
        "url": "https://devicerts.com/devices/dhx-70h-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "xm-lite HYBRID C70",
        "url": "https://devicerts.com/devices/xm-lite-hybrid-c70",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dmc-04",
        "url": "https://devicerts.com/devices/prox-dmc-04",
        "model_reference": null,
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hybrid S70",
        "url": "https://devicerts.com/devices/hybrid-s70-ehd",
        "model_reference": "K220574",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-04-22",
        "open_recall": false
      },
      {
        "name": "Dhx-70H, Xtg-70H",
        "url": "https://devicerts.com/devices/dhx-70h-xtg-70h-ehd",
        "model_reference": "K221587",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2023-03-03",
        "open_recall": false
      },
      {
        "name": "Portable X-ray System (Model: MiniX-V, Mini X-S)",
        "url": "https://devicerts.com/devices/portable-x-ray-system-model-minix-v-mini-x-s-ehd",
        "model_reference": "K181891",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-08-10",
        "open_recall": false
      },
      {
        "name": "Hybrid C70",
        "url": "https://devicerts.com/devices/hybrid-c70-ehd",
        "model_reference": "K220579",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-09-01",
        "open_recall": false
      },
      {
        "name": "Dmc-07",
        "url": "https://devicerts.com/devices/minix-s-dmc-07",
        "model_reference": null,
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "C533314",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "DNV Product Assurance AS",
      "issued": "2024-06-21",
      "expires": "2029-06-21",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}