{
  "format": "devicerts.device.v1",
  "cite_as": "Kfbio, Ningbo Konfoong Bioinformation Tech Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/kfbio-1008 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/kfbio-1008",
    "json_url": "https://devicerts.com/devices/kfbio-1008.json",
    "markdown_url": "https://devicerts.com/devices/kfbio-1008.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
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    "registry_records_last_synced": "2026-10-24",
    "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/devices/kfbio-1008",
    "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."
  },
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            {
              "value": "06975330710353",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "06975330710261",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "06975330710278",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "06975330710391",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "W0599",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "W02069099",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "V92",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class A",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "Class I",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Special device type",
          "values": [
            {
              "value": "Software",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "System or procedure pack",
          "values": [
            {
              "value": "System which is a device in itself",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Germany",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Reagent",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "No",
              "registries": [
                "EUDAMED"
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          ]
        },
        {
          "label": "IVD instrument",
          "values": [
            {
              "value": "No",
              "registries": [
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              ]
            },
            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
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          ]
        },
        {
          "label": "Contains latex",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
          "values": [
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              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
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              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
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              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
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              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Contains substances of microbial origin",
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              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "IVD kit",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Self-testing",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Near-patient testing",
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              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Professional testing",
          "values": [
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              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Companion diagnostics",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "New device",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    }
  ]
}