{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "VIOL Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/viol-co-ltd (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/viol-co-ltd",
    "json_url": "https://devicerts.com/manufacturers/viol-co-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/viol-co-ltd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "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/viol-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": "VIOL Co., Ltd.",
    "url": "https://devicerts.com/manufacturers/viol-co-ltd",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "South Korea",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3009206941"
      },
      {
        "label": "DUNS",
        "value": "695654949"
      }
    ],
    "summary": "VIOL Co., Ltd. is a medical device manufacturer, with 22 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 22,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 18
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      },
      {
        "registry": "EUDAMED",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 22
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "AR Experts B.V.",
        "url": "https://devicerts.com/representatives/ar-experts-bv-nl-ar-000023989",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 22,
    "total": 22,
    "all_devices_url": "https://devicerts.com/manufacturers/viol-co-ltd",
    "items": [
      {
        "name": "Scarlet Pro (Scarlet Pro)",
        "url": "https://devicerts.com/devices/scarlet-pro-scarlet-pro-gei",
        "model_reference": "K253859",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-08-27",
        "open_recall": false
      },
      {
        "name": "Cellinew",
        "url": "https://devicerts.com/devices/cellinew-cellinew",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Foot Switch F/S-Hrf-Blue",
        "url": "https://devicerts.com/devices/foot-switch-f-s-hrf-blue",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scarlet Srf",
        "url": "https://devicerts.com/devices/scarlet-srf-scarlet-srf",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CELLINEW Foot switch",
        "url": "https://devicerts.com/devices/cellinew-foot-switch-cellinew-foot-switch",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Foot Switch F/S",
        "url": "https://devicerts.com/devices/foot-switch-f-s",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Consumable Tip",
        "url": "https://devicerts.com/devices/consumable-tip-consumable-tip-5c14c7b0",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "XA25 J25BS",
        "url": "https://devicerts.com/devices/xa25-j25bs",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cellinew Tip CE25",
        "url": "https://devicerts.com/devices/cellinew-tip-ce25",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "XW18 J18BS",
        "url": "https://devicerts.com/devices/xw18-j18bs",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hand Piece H/S_02",
        "url": "https://devicerts.com/devices/hand-piece-h-s_02",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cellinew Tip CF40",
        "url": "https://devicerts.com/devices/cellinew-tip-cf40",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Consumable Tip",
        "url": "https://devicerts.com/devices/consumable-tip-consumable-tip-9eb60017",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Foot switch F/S-B",
        "url": "https://devicerts.com/devices/foot-switch-f-s-b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Celfirm",
        "url": "https://devicerts.com/devices/celfirm-celfirm",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scarlet Pro",
        "url": "https://devicerts.com/devices/scarlet-pro-scarlet-pro",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hand Piece H/S_03",
        "url": "https://devicerts.com/devices/hand-piece-h-s_03",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CELLINEW Handpiece",
        "url": "https://devicerts.com/devices/cellinew-handpiece-cellinew-handpiece",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Handpiece P/B",
        "url": "https://devicerts.com/devices/handpiece-p-b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scarlet Srf",
        "url": "https://devicerts.com/devices/scarlet-srf-gei",
        "model_reference": "K180872",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-10-11",
        "open_recall": false
      },
      {
        "name": "Cellinew",
        "url": "https://devicerts.com/devices/cellinew-gei",
        "model_reference": "K240897",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2024-11-26",
        "open_recall": false
      },
      {
        "name": "Celfirm",
        "url": "https://devicerts.com/devices/celfirm-gei",
        "model_reference": "K172023",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-10-13",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}