{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Sedatelec. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/sedatelec (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/sedatelec",
    "json_url": "https://devicerts.com/manufacturers/sedatelec.json",
    "markdown_url": "https://devicerts.com/manufacturers/sedatelec.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": "2026-11-15",
    "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/sedatelec",
    "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": "Sedatelec",
    "url": "https://devicerts.com/manufacturers/sedatelec",
    "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"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "FR-MF-000020946"
      },
      {
        "label": "DUNS",
        "value": "266031462"
      },
      {
        "label": "Other registry ID",
        "value": "5711"
      }
    ],
    "summary": "Sedatelec is a medical device manufacturer based in France, with 48 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa and I; FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 48,
    "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": "EUDAMED",
        "devices": 35
      },
      {
        "registry": "FDA GUDID",
        "devices": 31
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIa",
        "devices": 29
      },
      {
        "class": "FDA Class II",
        "devices": 7
      },
      {
        "class": "FDA Class I",
        "devices": 6
      },
      {
        "class": "EU Class I",
        "devices": 3
      },
      {
        "class": "EU Class IIb",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "A01",
        "name": "Needles",
        "url": "https://devicerts.com/categories/emdn/A01",
        "devices": 25
      },
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 9
      },
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 48,
    "total": 48,
    "all_devices_url": "https://devicerts.com/manufacturers/sedatelec",
    "items": [
      {
        "name": "Module Acuneedle",
        "url": "https://devicerts.com/devices/module-acuneedle-113549",
        "model_reference": "113549",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PAL250 Pressure feeler 250g",
        "url": "https://devicerts.com/devices/pal250-pressure-feeler-250g-103304",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "EASYO 1 - Multi Pressure Feeler",
        "url": "https://devicerts.com/devices/easyo-1-multi-pressure-feeler-112353",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp ASPTSOLO25",
        "url": "https://devicerts.com/devices/asp-110635",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PAL130 Pressure feeler 130g",
        "url": "https://devicerts.com/devices/pal130-pressure-feeler-130g-103609",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp Asptest",
        "url": "https://devicerts.com/devices/asp-110640",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BAT02 Glass rods",
        "url": "https://devicerts.com/devices/bat02-glass-rods-103607",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp Aspmtest",
        "url": "https://devicerts.com/devices/asp-113207",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PAL400 Pressure feeler 400g",
        "url": "https://devicerts.com/devices/pal400-pressure-feeler-400g-103610",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp ASPGSOLO25",
        "url": "https://devicerts.com/devices/asp-110634",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp ASPASOLO25",
        "url": "https://devicerts.com/devices/asp-110633",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PAL650 Pressure feeler 650g",
        "url": "https://devicerts.com/devices/pal650-pressure-feeler-650g-103611",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "FOREVER NEEDLE REGULAR (1x80)",
        "url": "https://devicerts.com/devices/forever-needle-regular-1x80-110488",
        "model_reference": "110488",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original GOLD 80",
        "url": "https://devicerts.com/devices/asp-original-gold-80-110625",
        "model_reference": "110625",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PREMIO 30 EVO Laser Duo",
        "url": "https://devicerts.com/devices/premio-30-evo-laser-duo-112048",
        "model_reference": "112048",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "APEX Gold 96",
        "url": "https://devicerts.com/devices/apex-gold-96-113276",
        "model_reference": "113276",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original TITANIUM 8",
        "url": "https://devicerts.com/devices/asp-original-titanium-8-110638",
        "model_reference": "110638",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sedatelec Asp Acupuncture Needles",
        "url": "https://devicerts.com/devices/sedatelec-asp-acupuncture-needles-mqx",
        "model_reference": "K983798",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-08-27",
        "open_recall": false
      },
      {
        "name": "Dn Acupunture Needles",
        "url": "https://devicerts.com/devices/dn-acupunture-needles-mqx",
        "model_reference": "K983800",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1999-08-27",
        "open_recall": false
      },
      {
        "name": "Premio 20DT",
        "url": "https://devicerts.com/devices/premio-20dt-111672",
        "model_reference": "111672",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Apex 96",
        "url": "https://devicerts.com/devices/apex-96-113275",
        "model_reference": "113275",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original GOLD 64",
        "url": "https://devicerts.com/devices/asp-original-gold-64-113209",
        "model_reference": "113209",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Perma-Klick 96",
        "url": "https://devicerts.com/devices/perma-klick-96-113281",
        "model_reference": "113281",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PREMIO 32 EVO laser A-G program",
        "url": "https://devicerts.com/devices/premio-32-evo-laser-a-g-program-112049",
        "model_reference": "112049",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PREMIO 32D EVO laser",
        "url": "https://devicerts.com/devices/premio-32d-evo-laser-112685",
        "model_reference": "112685",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Premio 20D",
        "url": "https://devicerts.com/devices/premio-20d-112802",
        "model_reference": "112802",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Agistim Duo",
        "url": "https://devicerts.com/devices/agistim-duo-108268",
        "model_reference": "108268",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original CLASSIC 64",
        "url": "https://devicerts.com/devices/asp-original-classic-64-113208",
        "model_reference": "113208",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Perma-Klick GOLD 96",
        "url": "https://devicerts.com/devices/perma-klick-gold-96-113282",
        "model_reference": "113282",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Module Acutrode",
        "url": "https://devicerts.com/devices/module-acutrode-113548",
        "model_reference": "113548",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original TITANIUM 80",
        "url": "https://devicerts.com/devices/asp-original-titanium-80-110626",
        "model_reference": "110626",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original CLASSIC 200",
        "url": "https://devicerts.com/devices/asp-original-classic-200-110614",
        "model_reference": "110614",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original CLASSIC 80",
        "url": "https://devicerts.com/devices/asp-original-classic-80-110624",
        "model_reference": "110624",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi CLASSIC 120",
        "url": "https://devicerts.com/devices/asp-multi-classic-120-113204",
        "model_reference": "113204",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original TITANIUM 64",
        "url": "https://devicerts.com/devices/asp-original-titanium-64-113210",
        "model_reference": "113210",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi CLASSIC 320",
        "url": "https://devicerts.com/devices/asp-multi-classic-320-113201",
        "model_reference": "113201",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp Perma Regular 8",
        "url": "https://devicerts.com/devices/asp-perma-regular-8-111181",
        "model_reference": "111181",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original TITANIUM 200",
        "url": "https://devicerts.com/devices/asp-original-titanium-200-110616",
        "model_reference": "110616",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PREMIO 10 - Moxa",
        "url": "https://devicerts.com/devices/premio-10-moxa-111237",
        "model_reference": "111237",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original GOLD 8",
        "url": "https://devicerts.com/devices/asp-original-gold-8-110637",
        "model_reference": "110637",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Premio 40 Light",
        "url": "https://devicerts.com/devices/premio-40-light-112953",
        "model_reference": "112953",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi GOLD 320",
        "url": "https://devicerts.com/devices/asp-multi-gold-320-113202",
        "model_reference": "113202",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original CLASSIC 8",
        "url": "https://devicerts.com/devices/asp-original-classic-8-110636",
        "model_reference": "110636",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi TITANIUM 120",
        "url": "https://devicerts.com/devices/asp-multi-titanium-120-113206",
        "model_reference": "113206",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Original GOLD 200",
        "url": "https://devicerts.com/devices/asp-original-gold-200-110615",
        "model_reference": "110615",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi GOLD 120",
        "url": "https://devicerts.com/devices/asp-multi-gold-120-113205",
        "model_reference": "113205",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ASP Multi TITANIUM 320",
        "url": "https://devicerts.com/devices/asp-multi-titanium-320-113203",
        "model_reference": "113203",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Asp Perma Regular 80",
        "url": "https://devicerts.com/devices/asp-perma-regular-80-111180",
        "model_reference": "111180",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "G15 015735 0033",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "TÜV SÜD Product Service GmbH",
      "issued": "2026-06-17",
      "expires": "2030-06-03",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}