{
  "format": "devicerts.device.v1",
  "cite_as": "Hamilton-C6 160021, Hamilton Medical AG. deviCERTS medical device catalogue. https://devicerts.com/devices/hamilton-c6-160021 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/hamilton-c6-160021",
    "json_url": "https://devicerts.com/devices/hamilton-c6-160021.json",
    "markdown_url": "https://devicerts.com/devices/hamilton-c6-160021.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-11-09",
    "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/hamilton-c6-160021",
    "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": "Hamilton-C6 160021",
    "registry_name": "HAMILTON-C6 160021",
    "url": "https://devicerts.com/devices/hamilton-c6-160021",
    "manufacturer": {
      "name": "Hamilton Medical AG",
      "url": "https://devicerts.com/manufacturers/hamilton-medical-ag",
      "country": "Switzerland",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIb",
        "system": "EU MDR"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "160021",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "07630002808590",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "76300028PN160021ZW",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K201658",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "CBK"
    ],
    "emdn": [
      {
        "code": "R9099",
        "term": "RESPIRATORY AND ANAESTHESIA DEVICES - OTHER"
      }
    ],
    "gmdn": [
      {
        "code": "42411",
        "term": "Neonatal/adult intensive-care ventilator"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "76300028PN160021ZW",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "07630002808590",
      "date": "2026-09-02",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "07630002808590",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2022-01-26",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K201658",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-12-11",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-2328-2025",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2025-06-03",
      "reason": "A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process.  This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.",
      "applies": "this device",
      "via": "K201658"
    },
    {
      "number": "Z-2020-2024",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2024-05-15",
      "reason": "Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.",
      "applies": "this device",
      "via": "K201658"
    },
    {
      "number": "Z-1429-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-03-14",
      "reason": "Software error causes, safety ventilation, in which ventilation continues in the \"safety ventilation\" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.",
      "applies": "this device",
      "via": "K201658"
    },
    {
      "number": "Z-0267-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2022-09-22",
      "reason": "Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.",
      "applies": "this device",
      "via": "K201658"
    },
    {
      "number": "Z-1525-2022",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2022-06-27",
      "reason": "Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed",
      "applies": "this device",
      "via": "K201658"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
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            {
              "value": "HAMILTON-C6",
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            }
          ]
        },
        {
          "label": "Generic name",
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            {
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              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
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    },
    {
      "group": "Identifiers",
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        {
          "label": "FDA product code",
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            }
          ]
        },
        {
          "label": "EMDN code",
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            }
          ]
        },
        {
          "label": "GMDN term",
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            {
              "value": "Neonatal/adult intensive-care ventilator",
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                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
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          "label": "Device class",
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            {
              "value": "Class IIb",
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            },
            {
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          ]
        },
        {
          "label": "Regulation number",
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            {
              "value": "868.5895",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "EU registration type",
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            {
              "value": "Standard device",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "EU market of registration",
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            {
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            }
          ]
        },
        {
          "label": "GUDID distribution status",
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                "FDA GUDID (AccessGUDID)"
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            }
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          "label": "MRI safety",
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        {
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        {
          "label": "Serial number",
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          "label": "Manufacturing date",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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        },
        {
          "label": "Supplied sterile",
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                "FDA GUDID (AccessGUDID)"
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            }
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        {
          "label": "Sterilise before use",
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        {
          "label": "Implantable",
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        {
          "label": "Contains latex",
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          "label": "Expiration date",
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}