{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Viasonix Ltd. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/viasonix-ltd (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/viasonix-ltd",
    "json_url": "https://devicerts.com/manufacturers/viasonix-ltd.json",
    "markdown_url": "https://devicerts.com/manufacturers/viasonix-ltd.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "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/manufacturers/viasonix-ltd",
    "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."
  },
  "manufacturer": {
    "name": "Viasonix Ltd",
    "url": "https://devicerts.com/manufacturers/viasonix-ltd",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Israel",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "IL-MF-000021015"
      },
      {
        "label": "DUNS",
        "value": "533070236"
      }
    ],
    "summary": "Viasonix Ltd is a medical device manufacturer based in Israel, with 44 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 44,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 36
      },
      {
        "registry": "EUDAMED",
        "devices": 32
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 35
      },
      {
        "class": "EU Class IIa",
        "devices": 9
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 9
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Arazy Group GmbH",
        "url": "https://devicerts.com/representatives/arazy-group-gmbh-de-ar-000007685",
        "country": "Germany"
      }
    ]
  },
  "devices": {
    "shown": 44,
    "total": 44,
    "all_devices_url": "https://devicerts.com/manufacturers/viasonix-ltd",
    "items": [
      {
        "name": "Viasonix 1.6MHz probe",
        "url": "https://devicerts.com/devices/viasonix-1-6mhz-probe-pvc0338",
        "model_reference": "PVC0338",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Viasonix 2 MHz PW Monitoring Doppler probe 5m cable",
        "url": "https://devicerts.com/devices/viasonix-2-mhz-pw-monitoring-doppler-probe-5m-cable-pvc0337",
        "model_reference": "PVC0337",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin Xpress",
        "url": "https://devicerts.com/devices/dolphin-xpress",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Viasonix 2MHz probe",
        "url": "https://devicerts.com/devices/viasonix-2mhz-probe-pvc0333",
        "model_reference": "PVC0333",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Viasonix 2 MHz PW Monitoring Doppler probe 2m cable",
        "url": "https://devicerts.com/devices/viasonix-2-mhz-pw-monitoring-doppler-probe-2m-cable-pvc0336",
        "model_reference": "PVC0336",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin MAX",
        "url": "https://devicerts.com/devices/dolphin-max",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "2 MHz monitoring, 5 meter cable",
        "url": "https://devicerts.com/devices/2-mhz-monitoring-2-mhz-monitoring-5-m",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "1.6 MHz probe",
        "url": "https://devicerts.com/devices/1-6-mhz-probe-1-6-mhz-probe",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin 4D",
        "url": "https://devicerts.com/devices/dolphin-4d-f69618a2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 2.5",
        "url": "https://devicerts.com/devices/pressure-cuff-size-2-5-pressure-cuff-size-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "4 MHz probe",
        "url": "https://devicerts.com/devices/4-mhz-probe-4-mhz-probe",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Disk PPG sensor",
        "url": "https://devicerts.com/devices/disk-ppg-sensor-disk-ppg-sensor",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 7",
        "url": "https://devicerts.com/devices/pressure-cuff-size-7-pressure-cuff-size-7",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fingerclip PPG sensor",
        "url": "https://devicerts.com/devices/fingerclip-ppg-sensor-fingerclip-ppg-senso",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "8 MHz probe",
        "url": "https://devicerts.com/devices/8-mhz-probe-8-mhz-probe",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 10",
        "url": "https://devicerts.com/devices/pressure-cuff-size-10-pressure-cuff-size-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Toe Clip PPG Sensor",
        "url": "https://devicerts.com/devices/toe-clip-ppg-sensor-pvc0143",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 12L",
        "url": "https://devicerts.com/devices/pressure-cuff-size-12l-pressure-cuff-size-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LiteWalk Sandals Medium",
        "url": "https://devicerts.com/devices/litewalk-sandals-pvc0268-m",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LiteWalk Sandals Small",
        "url": "https://devicerts.com/devices/litewalk-sandals-pvc0268-s",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 1.6",
        "url": "https://devicerts.com/devices/pressure-cuff-size-1-6-pressure-cuff-size-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "2 MHz monitoring",
        "url": "https://devicerts.com/devices/2-mhz-monitoring-2-mhz-monitoring",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 12",
        "url": "https://devicerts.com/devices/pressure-cuff-size-12-pressure-cuff-size-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "4 MHz probe",
        "url": "https://devicerts.com/devices/4-mhz-probe-pvc0330",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin/XF Robot Accessory",
        "url": "https://devicerts.com/devices/dolphin-xf-robot-accessory-dolphin-xf-robot-acc",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Detachable PPG Clip sensor",
        "url": "https://devicerts.com/devices/detachable-ppg-clip-sensor-detachable-ppg-clip",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10 MHz probe",
        "url": "https://devicerts.com/devices/10-mhz-probe-pvc0332",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin IQ",
        "url": "https://devicerts.com/devices/dolphin-iq-7551b871",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LiteWalk Sandals Large",
        "url": "https://devicerts.com/devices/litewalk-sandals-pvc0268-l",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pressure Cuff Size 1.9",
        "url": "https://devicerts.com/devices/pressure-cuff-size-1-9-pressure-cuff-size-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LiteWalk",
        "url": "https://devicerts.com/devices/litewalk-litewalk",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "10 MHz probe",
        "url": "https://devicerts.com/devices/10-mhz-probe-10-mhz-probe",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "2 MHz probe",
        "url": "https://devicerts.com/devices/2-mhz-probe-2-mhz-probe",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin IQ",
        "url": "https://devicerts.com/devices/dolphin-iq",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "8 MHz probe",
        "url": "https://devicerts.com/devices/8-mhz-probe-pvc0331",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin/IQ, Dolphin/4D and Dolphin/MAX",
        "url": "https://devicerts.com/devices/dolphin-iq-dolphin-4d-and-dolphin-max-iyn",
        "model_reference": "K191023",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-05-16",
        "open_recall": false
      },
      {
        "name": "LiteWalk",
        "url": "https://devicerts.com/devices/litewalk-irp",
        "model_reference": "K192607",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-12-19",
        "open_recall": false
      },
      {
        "name": "Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory",
        "url": "https://devicerts.com/devices/dolphin-iq-dolphin-4d-and-dolphin-max-with-dolphin-xf-robot-iyn",
        "model_reference": "K202742",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2021-01-25",
        "open_recall": false
      },
      {
        "name": "Dolphin/IQ and Dolphin/4D",
        "url": "https://devicerts.com/devices/dolphin-iq-and-dolphin-4d-iyn",
        "model_reference": "K170859",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-11-14",
        "open_recall": false
      },
      {
        "name": "Falcon/Pro",
        "url": "https://devicerts.com/devices/falcon-pro-pvc0077",
        "model_reference": "PVC0077",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dolphin/4D",
        "url": "https://devicerts.com/devices/dolphin-4d-pvc0201",
        "model_reference": "PVC0201",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Falcon/ABI+",
        "url": "https://devicerts.com/devices/falcon-abi-pvc0079",
        "model_reference": "PVC0079",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Falcon/Xpress",
        "url": "https://devicerts.com/devices/falcon-xpress-pvc0400",
        "model_reference": "PVC0400",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Falcon/Quad",
        "url": "https://devicerts.com/devices/falcon-quad-pvc0078",
        "model_reference": "PVC0078",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "3903018CE01",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "DEKRA Certification B.V.",
      "issued": "2025-06-23",
      "expires": "2028-01-01",
      "status": "amended",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}