{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Tentech Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/tentech-co-ltd (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/tentech-co-ltd",
    "json_url": "https://devicerts.com/manufacturers/tentech-co-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/tentech-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/"
      }
    ],
    "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/tentech-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": "Tentech Co., Ltd.",
    "url": "https://devicerts.com/manufacturers/tentech-co-ltd",
    "registered_as": "TENTECH Inc.",
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "South Korea",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer",
      "Part of a group"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000035109"
      }
    ],
    "summary": "Tentech Co., Ltd. is a medical device manufacturer based in South Korea, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 27,
    "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": 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": 16
      },
      {
        "registry": "EUDAMED",
        "devices": 10
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 17
      },
      {
        "class": "EU Class IIb",
        "devices": 10
      }
    ],
    "top_emdn_categories": [
      {
        "code": "K02",
        "name": "Electrosurgery devices, single-use",
        "url": "https://devicerts.com/categories/emdn/K02",
        "devices": 10
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "TENTECH Inc.",
      "url": "https://devicerts.com/manufacturers/tentech-inc"
    },
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 27,
    "total": 27,
    "all_devices_url": "https://devicerts.com/manufacturers/tentech-co-ltd",
    "items": [
      {
        "name": "10THERMA / Xtherma Tip TMET0.25-300/ XMET0.25-300",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmet0-25-300-xmet0-25-300",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMET0.25-600/ XMET0.25-600",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmet0-25-600-xmet0-25-600",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT4.0-600/ XMFT4.0-600",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-600-xmft4-0-600",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT4.0-900/ XMFT4.0-900",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-900-xmft4-0-900",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT4.0-300/ XMFT4.0-300",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft4-0-300-xmft4-0-300",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT5.0-300/ XMFT5.0-300",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-300-xmft5-0-300",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT5.0-600/ XMFT5.0-600",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-600-xmft5-0-600",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMFT5.0-900/ XMFT5.0-900",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmft5-0-900-xmft5-0-900",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMBT20.0-1000/ XMBT20.0-1000",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmbt20-0-1000-xmbt20-0-1000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA / Xtherma Tip TMBT20.0-500/ XMBT20.0-500",
        "url": "https://devicerts.com/devices/10therma-xtherma-tip-tmbt20-0-500-xmbt20-0-500",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Xtherma-H/P",
        "url": "https://devicerts.com/devices/xtherma-xtherma-h-p",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10PL-Body",
        "url": "https://devicerts.com/devices/10pl-10pl-body",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA TMHP02",
        "url": "https://devicerts.com/devices/10therma-tmhp02",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "XTHERMA-Body",
        "url": "https://devicerts.com/devices/xtherma-xtherma-body",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA TMSY02",
        "url": "https://devicerts.com/devices/10therma-tmsy02",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10PL-H/P",
        "url": "https://devicerts.com/devices/10pl-10pl-h-p",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10PL",
        "url": "https://devicerts.com/devices/10pl-onf",
        "model_reference": "K220794",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2022-11-10",
        "open_recall": false
      },
      {
        "name": "10THERMA Coupling Fluid",
        "url": "https://devicerts.com/devices/10therma-coupling-fluid-tmcf01",
        "model_reference": "TMCF01",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Electrode",
        "url": "https://devicerts.com/devices/10therma-electrode-tmet0-25-600",
        "model_reference": "TMET0.25-600",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Electrode",
        "url": "https://devicerts.com/devices/10therma-electrode-tmft4-0-600",
        "model_reference": "TMFT4.0-600",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Handpiece",
        "url": "https://devicerts.com/devices/10therma-handpiece-tmhp01",
        "model_reference": "TMHP01",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Cooling Gas",
        "url": "https://devicerts.com/devices/10therma-cooling-gas-tmcg01",
        "model_reference": "TMCG01",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Foot Switch",
        "url": "https://devicerts.com/devices/10therma-foot-switch-tmfs01",
        "model_reference": "TMFS01",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA",
        "url": "https://devicerts.com/devices/10therma-10therma",
        "model_reference": null,
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Return Pad",
        "url": "https://devicerts.com/devices/10therma-return-pad-tmrp01",
        "model_reference": "TMRP01",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA-Bk",
        "url": "https://devicerts.com/devices/10therma-bk-10therma-bk",
        "model_reference": null,
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10THERMA Electrode",
        "url": "https://devicerts.com/devices/10therma-electrode-tmft5-0-900",
        "model_reference": "TMFT5.0-900",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "2025-MDR/QS-054/A",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "3EC International a.s.",
      "issued": "2026-03-10",
      "expires": "2030-11-11",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}