{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Zerone Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/zerone-co-ltd (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/zerone-co-ltd",
    "json_url": "https://devicerts.com/manufacturers/zerone-co-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/zerone-co-ltd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "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/zerone-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": "Zerone Co., Ltd.",
    "url": "https://devicerts.com/manufacturers/zerone-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"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000014148"
      }
    ],
    "summary": "Zerone Co., Ltd. is a medical device manufacturer based in South Korea, with 29 devices listed in EUDAMED (EU Class IIb and IIa) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 29,
    "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": "EUDAMED",
        "devices": 29
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIb",
        "devices": 21
      },
      {
        "class": "EU Class IIa",
        "devices": 8
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 21
      },
      {
        "code": "K01",
        "name": "Endotherapy devices",
        "url": "https://devicerts.com/categories/emdn/K01",
        "devices": 5
      },
      {
        "code": "L18",
        "name": "Electrosurgery instruments, reusable",
        "url": "https://devicerts.com/categories/emdn/L18",
        "devices": 3
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "CMC Medical Devices & Drugs SL",
        "url": "https://devicerts.com/representatives/cmc-medical-devices-drugs-sl-es-ar-000000293",
        "country": "Spain"
      }
    ]
  },
  "devices": {
    "shown": 29,
    "total": 29,
    "all_devices_url": "https://devicerts.com/manufacturers/zerone-co-ltd",
    "items": [
      {
        "name": "Vi-Sealer",
        "url": "https://devicerts.com/devices/vi-sealer-vs02-02r",
        "model_reference": "VS02-02R",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zero50",
        "model_reference": "ZERO50",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tropian",
        "url": "https://devicerts.com/devices/tropian-ztc-10",
        "model_reference": "ZTC-10",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-ace-400",
        "model_reference": "ACE-400",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Syringe pump",
        "url": "https://devicerts.com/devices/syringe-pump-syrin-z-4000",
        "model_reference": "SYRIN-Z 4000",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tropian",
        "url": "https://devicerts.com/devices/tropian-zt-12f",
        "model_reference": "ZT-12F",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ECG Analysis System",
        "url": "https://devicerts.com/devices/ecg-analysis-system-cz-430",
        "model_reference": "CZ-430",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ultrasonic Surgical Unit",
        "url": "https://devicerts.com/devices/ultrasonic-surgical-unit-ultra-z",
        "model_reference": "ULTRA-Z",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Suction-irrigation pumps",
        "url": "https://devicerts.com/devices/suction-irrigation-pumps-zp-1000",
        "model_reference": "ZP-1000",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-ace-200s",
        "model_reference": "ACE-200S",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-doctanz200",
        "model_reference": "DOCTANZ200",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zeus-vision",
        "model_reference": "ZEUS VISION",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-ace-vision",
        "model_reference": "ACE VISION",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Infusion pump",
        "url": "https://devicerts.com/devices/infusion-pump-infu-z-1000",
        "model_reference": "INFU-Z 1000",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vi-Sealer",
        "url": "https://devicerts.com/devices/vi-sealer-vs01-02r",
        "model_reference": "VS01-02R",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-argon-z",
        "model_reference": "ARGON-Z",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zeus-200",
        "model_reference": "ZEUS-200",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-doctanz150",
        "model_reference": "DOCTANZ150",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zeus-200s",
        "model_reference": "ZEUS-200S",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zeus-400",
        "model_reference": "ZEUS-400",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-doctanz400",
        "model_reference": "DOCTANZ400",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tropian",
        "url": "https://devicerts.com/devices/tropian-zt-20",
        "model_reference": "ZT-20",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Infusion pump",
        "url": "https://devicerts.com/devices/infusion-pump-infu-z-4000",
        "model_reference": "INFU-Z 4000",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tropian",
        "url": "https://devicerts.com/devices/tropian-ztc-30",
        "model_reference": "ZTC-30",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vi-Sealer",
        "url": "https://devicerts.com/devices/vi-sealer-vs02-01r",
        "model_reference": "VS02-01R",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Electrosurgical Unit",
        "url": "https://devicerts.com/devices/electrosurgical-unit-zeus-prime",
        "model_reference": "ZEUS PRIME",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ECG Analysis System (and Spirometry)",
        "url": "https://devicerts.com/devices/ecg-analysis-system-and-spirometry-cz-800",
        "model_reference": "CZ-800",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tropian",
        "url": "https://devicerts.com/devices/tropian-zt-22f",
        "model_reference": "ZT-22F",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Infusion pump",
        "url": "https://devicerts.com/devices/infusion-pump-infu-z-2000",
        "model_reference": "INFU-Z 2000",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}