{
  "format": "devicerts.device.v1",
  "cite_as": "Alivia, TensCare Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/alivia-k-alivia (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/alivia-k-alivia",
    "json_url": "https://devicerts.com/devices/alivia-k-alivia.json",
    "markdown_url": "https://devicerts.com/devices/alivia-k-alivia.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/alivia-k-alivia",
    "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": "Alivia",
    "registry_name": "Alivia",
    "url": "https://devicerts.com/devices/alivia-k-alivia",
    "manufacturer": {
      "name": "TensCare Ltd",
      "url": "https://devicerts.com/manufacturers/tenscare-ltd",
      "country": "United Kingdom",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union"
    },
    "classification": [
      {
        "class": "Class IIa",
        "system": "EU MDR"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "05033435136278",
            "registries": [
              "EUDAMED"
            ]
          },
          {
            "value": "05033435135967",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "5033435K00138DSU",
            "registries": [
              "EUDAMED"
            ]
          },
          {
            "value": "5033435K00138ZU",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      }
    ],
    "product_codes": [],
    "emdn": [
      {
        "code": "U070399",
        "term": "PELVIC FLOOR REHABILITATION DEVICES - OTHER"
      }
    ],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "5033435K00138DSU",
      "number_label": "Basic UDI-DI",
      "device_udi_di": null,
      "date": "2024-09-02",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "K-ALIVIA",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "05033435136278",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "05033435135967",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Basic UDI-DI",
          "values": [
            {
              "value": "5033435K00138DSU",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "5033435K00138ZU",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EMDN code",
          "values": [
            {
              "value": "U070399",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIa",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "System or procedure pack",
          "values": [
            {
              "value": "Procedure pack",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
          "values": [
            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "System or procedure pack",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "Netherlands",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Medical purpose",
          "values": [
            {
              "value": "Alivia is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence and is suitable for use by all who can control the device and understand the instructions.\nAlivia may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease.",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "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"
              ]
            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        }
      ]
    }
  ]
}