{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Azmed. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/azmed (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/azmed",
    "json_url": "https://devicerts.com/manufacturers/azmed.json",
    "markdown_url": "https://devicerts.com/manufacturers/azmed.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "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/azmed",
    "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": "Azmed",
    "url": "https://devicerts.com/manufacturers/azmed",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "France",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "FR-MF-000014277"
      },
      {
        "label": "FDA FEI",
        "value": "3026753394"
      },
      {
        "label": "DUNS",
        "value": "271425256"
      }
    ],
    "summary": "Azmed is a medical device manufacturer based in France, with 9 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (FDA Class II; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 9,
    "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": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 3
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      },
      {
        "registry": "FDA GUDID",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 6
      },
      {
        "class": "EU Class IIa",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z11",
        "name": "Bioimaging and radiotherapy instruments",
        "url": "https://devicerts.com/categories/emdn/Z11",
        "devices": 3
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 9,
    "total": 9,
    "all_devices_url": "https://devicerts.com/manufacturers/azmed",
    "items": [
      {
        "name": "Rayvolve 7",
        "url": "https://devicerts.com/devices/rayvolve-7-394009b8",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rayvolve 7",
        "url": "https://devicerts.com/devices/rayvolve-7-ef5a557e",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rayvolve 7",
        "url": "https://devicerts.com/devices/rayvolve-7",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rayvolve",
        "url": "https://devicerts.com/devices/rayvolve-rayvolve-vm-cloud-ve-37700180",
        "model_reference": "Rayvolve - VM + Cloud (version 8)",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rayvolve AZchest",
        "url": "https://devicerts.com/devices/rayvolve-azchest-qbs",
        "model_reference": "K261378",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-08-28",
        "open_recall": false
      },
      {
        "name": "Rayvolve",
        "url": "https://devicerts.com/devices/rayvolve-rayvolve-on-premise-f4b6b667",
        "model_reference": "Rayvolve - On-premise (Version 5)",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rayvolve PTX-PE",
        "url": "https://devicerts.com/devices/rayvolve-ptx-pe-qfm",
        "model_reference": "K243808",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-03-21",
        "open_recall": false
      },
      {
        "name": "Rayvolve LN",
        "url": "https://devicerts.com/devices/rayvolve-ln-myn",
        "model_reference": "K243831",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2025-03-26",
        "open_recall": false
      },
      {
        "name": "Rayvolve",
        "url": "https://devicerts.com/devices/rayvolve-rayvolve-on-premise",
        "model_reference": "Rayvolve- On premise (Version 2)",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "MDR 731678",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2026-04-08",
      "expires": "2031-04-13",
      "status": "reissued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}