{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Deka M.E.L.A. SRL. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/deka-mela-srl (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/deka-mela-srl",
    "json_url": "https://devicerts.com/manufacturers/deka-mela-srl.json",
    "markdown_url": "https://devicerts.com/manufacturers/deka-mela-srl.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 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": "2026-11-14",
    "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/deka-mela-srl",
    "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": "Deka M.E.L.A. SRL",
    "url": "https://devicerts.com/manufacturers/deka-mela-srl",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Italy",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "IT-MF-000007389"
      }
    ],
    "summary": "Deka M.E.L.A. SRL is a medical device manufacturer based in Italy, with 116 devices listed in EUDAMED and FDA GUDID (EU Class IIb, IIa and I) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 116,
    "devices_note": null,
    "certificates": 3,
    "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": 116
      },
      {
        "registry": "FDA GUDID",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIb",
        "devices": 109
      },
      {
        "class": "EU Class IIa",
        "devices": 4
      },
      {
        "class": "EU Class I",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 115
      },
      {
        "code": "X04",
        "name": "Equipment without an intended medical purpose intended to be used to reduce, remove or destroy adipose tissue",
        "url": "https://devicerts.com/categories/emdn/X04",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 116,
    "all_devices_url": "https://devicerts.com/manufacturers/deka-mela-srl",
    "items": [
      {
        "name": "Toro",
        "url": "https://devicerts.com/devices/toro-m136a1",
        "model_reference": "M136A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan V2LR",
        "url": "https://devicerts.com/devices/hiscan-v2lr-f52001",
        "model_reference": "F52001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan DOT +",
        "url": "https://devicerts.com/devices/hiscan-dot-f269a1",
        "model_reference": "F269A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "EasySpot Micromanipulator",
        "url": "https://devicerts.com/devices/easyspot-micromanipulator-n183g1",
        "model_reference": "N183G1",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Matrix Dot",
        "url": "https://devicerts.com/devices/matrix-dot-e291a1",
        "model_reference": "E291A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Onda",
        "url": "https://devicerts.com/devices/onda-m116a1",
        "model_reference": "M116A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Matrix Dot",
        "url": "https://devicerts.com/devices/matrix-dot-f57401",
        "model_reference": "F57401",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SYNCHRO REPLA:Y Excellium HP",
        "url": "https://devicerts.com/devices/synchro-repla-y-excellium-hp-m104i1",
        "model_reference": "M104I1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motus Pro",
        "url": "https://devicerts.com/devices/motus-pro-m130j1",
        "model_reference": "M130J1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Helix",
        "url": "https://devicerts.com/devices/helix-m133d1",
        "model_reference": "M133D1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Scar 3 Pro",
        "url": "https://devicerts.com/devices/scar-3-pro-f540a1",
        "model_reference": "F540A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motus Pro",
        "url": "https://devicerts.com/devices/motus-pro-m130i1",
        "model_reference": "M130I1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dot Pro",
        "url": "https://devicerts.com/devices/dot-pro-f54001",
        "model_reference": "F54001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "DermaSCAN",
        "url": "https://devicerts.com/devices/dermascan-f477d1",
        "model_reference": "F477D1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan DOT/RF",
        "url": "https://devicerts.com/devices/hiscan-dot-rf-f26901",
        "model_reference": "F26901",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "DermaSCAN",
        "url": "https://devicerts.com/devices/dermascan-f477l1",
        "model_reference": "F477L1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartXide PRO",
        "url": "https://devicerts.com/devices/smartxide-pro-m079bh1",
        "model_reference": "M079BH1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan Surgical",
        "url": "https://devicerts.com/devices/hiscan-surgical-f16301",
        "model_reference": "F16301",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "EndoScan",
        "url": "https://devicerts.com/devices/endoscan-f26801",
        "model_reference": "F26801",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motus Pro",
        "url": "https://devicerts.com/devices/motus-pro-m130k1",
        "model_reference": "M130K1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Schwarzy",
        "url": "https://devicerts.com/devices/schwarzy-m124b1",
        "model_reference": "M124B1",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan V2LR",
        "url": "https://devicerts.com/devices/hiscan-v2lr-f397a1",
        "model_reference": "F397A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Red Touch",
        "url": "https://devicerts.com/devices/red-touch-m121a1",
        "model_reference": "M121A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan DOT S",
        "url": "https://devicerts.com/devices/hiscan-dot-s-f397c1",
        "model_reference": "F397C1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan V2LR",
        "url": "https://devicerts.com/devices/hiscan-v2lr-e124r1",
        "model_reference": "E124R1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Synchro Repla:y Premium 1.4.2",
        "url": "https://devicerts.com/devices/synchro-repla-y-premium-1-4-2-m104f1",
        "model_reference": "M104F1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duo Glide",
        "url": "https://devicerts.com/devices/duo-glide-m127a1",
        "model_reference": "M127A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan V2LR",
        "url": "https://devicerts.com/devices/hiscan-v2lr-f49701",
        "model_reference": "F49701",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartXide Punto 50",
        "url": "https://devicerts.com/devices/smartxide-punto-50-m118b1",
        "model_reference": "M118B1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Again Pro Plus",
        "url": "https://devicerts.com/devices/again-pro-plus-m126t1",
        "model_reference": "M126T1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "V2LR Pro",
        "url": "https://devicerts.com/devices/v2lr-pro-f54101",
        "model_reference": "F54101",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Onda Plus",
        "url": "https://devicerts.com/devices/onda-plus-m116m1",
        "model_reference": "M116M1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Smartxide Hs",
        "url": "https://devicerts.com/devices/smartxide-hs-m079q2",
        "model_reference": "M079Q2",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan DOT S",
        "url": "https://devicerts.com/devices/hiscan-dot-s-f346b1",
        "model_reference": "F346B1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Luxea",
        "url": "https://devicerts.com/devices/luxea-m117a1",
        "model_reference": "M117A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "V2LR Pro",
        "url": "https://devicerts.com/devices/v2lr-pro-f540b1",
        "model_reference": "F540B1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HiScan SCAR 3",
        "url": "https://devicerts.com/devices/hiscan-scar-3-f397b1",
        "model_reference": "F397B1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Synchro QS4",
        "url": "https://devicerts.com/devices/synchro-qs4-m109a1",
        "model_reference": "M109A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "DermaSCAN",
        "url": "https://devicerts.com/devices/dermascan-f479d1",
        "model_reference": "F479D1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Physiq 360",
        "url": "https://devicerts.com/devices/physiq-360-m134d1",
        "model_reference": "M134D1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Smartlipo",
        "url": "https://devicerts.com/devices/smartlipo-m053h2",
        "model_reference": "M053H2",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motus Ay",
        "url": "https://devicerts.com/devices/motus-ay-m115a1",
        "model_reference": "M115A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Smartxide Touch C60",
        "url": "https://devicerts.com/devices/smartxide-touch-c60-m110b1",
        "model_reference": "M110B1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Smart Us-20 D",
        "url": "https://devicerts.com/devices/smart-us-20-d-m079a1",
        "model_reference": "M079A1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bodylab",
        "url": "https://devicerts.com/devices/bodylab-m124h1",
        "model_reference": "M124H1",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Dot S Pro",
        "url": "https://devicerts.com/devices/dot-s-pro-f540c1",
        "model_reference": "F540C1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tricoscan",
        "url": "https://devicerts.com/devices/tricoscan-f269c1",
        "model_reference": "F269C1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Minisilk Ft",
        "url": "https://devicerts.com/devices/minisilk-ft-m081m2",
        "model_reference": "M081M2",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "µScan SCAR 3",
        "url": "https://devicerts.com/devices/uscan-scar-3-f479c1",
        "model_reference": "F479C1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motus Az+",
        "url": "https://devicerts.com/devices/motus-az-m130f1",
        "model_reference": "M130F1",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "G15 098416 0015",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "TÜV SÜD Product Service GmbH",
      "issued": "2026-06-22",
      "expires": "2031-09-20",
      "status": "reissued",
      "no_longer_listed": false
    },
    {
      "number": "277/MDR",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.",
      "issued": "2026-05-19",
      "expires": "2031-05-18",
      "status": "issued",
      "no_longer_listed": false
    },
    {
      "number": "G10 098416 0009",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "TÜV SÜD Product Service GmbH",
      "issued": "2025-04-23",
      "expires": "2026-09-20",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}