{
  "format": "devicerts.device.v1",
  "cite_as": "Diode Laser Therapy Systems, BEIJING UNT Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/diode-laser-therapy-systems-alpha (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/diode-laser-therapy-systems-alpha",
    "json_url": "https://devicerts.com/devices/diode-laser-therapy-systems-alpha.json",
    "markdown_url": "https://devicerts.com/devices/diode-laser-therapy-systems-alpha.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-23",
    "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/devices/diode-laser-therapy-systems-alpha",
    "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."
  },
  "device": {
    "name": "Diode Laser Therapy Systems",
    "registry_name": "Diode Laser Therapy Systems",
    "url": "https://devicerts.com/devices/diode-laser-therapy-systems-alpha",
    "manufacturer": {
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      "url": "https://devicerts.com/manufacturers/beijing-unt-technology-co-ltd",
      "country": "China",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDR"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "06973663791049",
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      {
        "label": "Basic UDI-DI",
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            "value": "697366379104P9",
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          {
            "value": "K212978",
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [
      {
        "code": "Z12011016",
        "term": "DIODE SURGICAL LASER"
      }
    ],
    "gmdn": [
      {
        "code": "58786",
        "term": "Dermatological diode laser system"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
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      "number": "06973663791049",
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      "date": "2024-04-25",
      "date_kind": "listed",
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    },
    {
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      "region": "European Union",
      "type": "CE/MDR",
      "number": "697366379104P9",
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    {
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      "date": "2024-02-26",
      "date_kind": "issued",
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      "expires": "2029-02-26",
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      "status": "Active",
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    },
    {
      "registry": "510(k)",
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      "device_udi_di": null,
      "date": "2021-11-10",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [
    {
      "number": "CN24/00001171",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "SGS Belgium NV",
      "issued": "2024-02-26",
      "expires": "2029-02-26",
      "status": "issued",
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    }
  ],
  "recalls": [],
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  "properties": [
    {
      "group": "Identity",
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        {
          "label": "Generic name",
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            {
              "value": "Dermatological diode laser system",
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        },
        {
          "label": "Model / reference",
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            }
          ]
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        {
          "label": "Direct marketing DI",
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        },
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          "label": "GMDN term",
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          "label": "EU registration type",
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          "label": "GUDID distribution status",
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      "group": "Clinical & Handling",
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          "label": "MRI safety",
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      "group": "Properties",
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              "value": "Yes",
              "registries": [
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          ]
        },
        {
          "label": "Supplied sterile",
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              "registries": [
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        {
          "label": "Sterilise before use",
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          "label": "Single use",
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          ]
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        {
          "label": "Implantable",
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        },
        {
          "label": "Contains latex",
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                "FDA GUDID (AccessGUDID)"
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        {
          "label": "Reprocessed single-use device",
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        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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              "registries": [
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        {
          "label": "Incorporates a substance derived from human blood or plasma",
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        {
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        {
          "label": "Contains endocrine-disrupting substances",
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          "label": "Administering medicine",
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          "label": "Measuring function",
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          "label": "Incorporates a medicinal substance",
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          "label": "Prescription use",
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        {
          "label": "Over-the-counter",
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          "label": "Convenience kit",
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        {
          "label": "Expiration date",
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}
