{
  "format": "devicerts.device.v1",
  "cite_as": "Core Fill Plus, YURIM MEDICAL Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/core-fill-plus-fine (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/core-fill-plus-fine",
    "json_url": "https://devicerts.com/devices/core-fill-plus-fine.json",
    "markdown_url": "https://devicerts.com/devices/core-fill-plus-fine.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-23",
    "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/core-fill-plus-fine",
    "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": "Core Fill Plus",
    "registry_name": "CORE FILL PLUS",
    "url": "https://devicerts.com/devices/core-fill-plus-fine",
    "manufacturer": {
      "name": "YURIM MEDICAL Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/yurim-medical-co-ltd",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "EU MDR"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08809684749135",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "880968473961COREFILLBS",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      }
    ],
    "product_codes": [],
    "emdn": [
      {
        "code": "X0303",
        "term": "SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE"
      }
    ],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "880968473961COREFILLBS",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "08809684749135",
      "date": "2026-06-29",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "2026-AXVI/QS-004",
      "number_label": null,
      "device_udi_di": null,
      "date": "2026-06-25",
      "date_kind": "issued",
      "decision_code": null,
      "expires": "2031-06-25",
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
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      "number_label": null,
      "device_udi_di": null,
      "date": "2026-06-25",
      "date_kind": "issued",
      "decision_code": null,
      "expires": "2031-06-25",
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      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [
    {
      "number": "2026-AXVI/QS-004",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "3EC International a.s.",
      "issued": "2026-06-25",
      "expires": "2031-06-25",
      "status": "issued",
      "no_longer_listed": false
    },
    {
      "number": "2026-AXVI/TD-004",
      "type": "Technical documentation",
      "legislation": "MDR",
      "notified_body": "3EC International a.s.",
      "issued": "2026-06-25",
      "expires": "2031-06-25",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "CORE FILL PLUS",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "CORE FILL PLUS FINE",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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        {
          "label": "Primary DI / UDI-DI",
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            {
              "value": "08809684749135",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
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            {
              "value": "880968473961COREFILLBS",
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              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "X0303",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class III",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Italy",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
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            {
              "value": "Yes",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reusable",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Measuring function",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    }
  ]
}