{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Osstell AB. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/osstell-ab (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/osstell-ab",
    "json_url": "https://devicerts.com/manufacturers/osstell-ab.json",
    "markdown_url": "https://devicerts.com/manufacturers/osstell-ab.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/"
      },
      {
        "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/osstell-ab",
    "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": "Osstell AB",
    "url": "https://devicerts.com/manufacturers/osstell-ab",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Sweden",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "SE-MF-000002162"
      },
      {
        "label": "FDA FEI",
        "value": "3004070020"
      },
      {
        "label": "DUNS",
        "value": "633171269"
      }
    ],
    "summary": "Osstell AB is a medical device manufacturer based in Sweden, with 158 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIa; FDA Class I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 158,
    "devices_note": null,
    "certificates": 0,
    "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": 152
      },
      {
        "registry": "EUDAMED",
        "devices": 147
      },
      {
        "registry": "FDA 510(k)",
        "devices": 4
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 140
      },
      {
        "class": "FDA Class I",
        "devices": 17
      },
      {
        "class": "EU Class IIa",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Q01",
        "name": "Dental devices",
        "url": "https://devicerts.com/categories/emdn/Q01",
        "devices": 141
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 158,
    "all_devices_url": "https://devicerts.com/manufacturers/osstell-ab",
    "items": [
      {
        "name": "Osstell SmartPeg Type 120",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-120-08086156",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell SmartPeg Type 121",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-121-08086157",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Reusable SmartPeg",
        "url": "https://devicerts.com/devices/reusable-smartpeg-ekx",
        "model_reference": "K261987",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2026-09-08",
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 123",
        "url": "https://devicerts.com/devices/smartpeg-type-123-08086159",
        "model_reference": "08086159",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 122",
        "url": "https://devicerts.com/devices/smartpeg-type-122-08086158",
        "model_reference": "08086158",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell Instrument",
        "url": "https://devicerts.com/devices/osstell-instrument-103100",
        "model_reference": "103100",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell Beacon",
        "url": "https://devicerts.com/devices/osstell-beacon-100668",
        "model_reference": "100668",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 119",
        "url": "https://devicerts.com/devices/smartpeg-type-119-08086155",
        "model_reference": "08086155",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell SmartPeg Type 41",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-41-100463",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "MEGA ISQ II Instrument Osstell MEGA ISQ II Instrument",
        "url": "https://devicerts.com/devices/mega-isq-ii-instrument-103100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Neoss SmartPeg Mount",
        "url": "https://devicerts.com/devices/neoss-smartpeg-mount-91075",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell SmartPeg Type 42",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-42-100464",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell SmartPeg Type 64",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-64-100555",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OsstellConnect Osstell OsstellConnect",
        "url": "https://devicerts.com/devices/osstellconnect-osstell-osstellconne",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell SmartPeg Type 70",
        "url": "https://devicerts.com/devices/osstell-smartpeg-type-70-100562",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NeoTell",
        "url": "https://devicerts.com/devices/neotell-91060",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell Classic Instrument",
        "url": "https://devicerts.com/devices/osstell-classic-instrument-08086148",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell Beacon Instrument Osstell Osstell Beacon Instrument",
        "url": "https://devicerts.com/devices/osstell-beacon-instrument-103000",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "DIO IDx Instrument Osstell DIO IDx Instrument",
        "url": "https://devicerts.com/devices/dio-idx-instrument-100501",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 95",
        "url": "https://devicerts.com/devices/smartpeg-type-95-100758",
        "model_reference": "100758",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 28",
        "url": "https://devicerts.com/devices/smartpeg-type-28-100432",
        "model_reference": "100432",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 32",
        "url": "https://devicerts.com/devices/smartpeg-type-32-100440",
        "model_reference": "100440",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 62",
        "url": "https://devicerts.com/devices/smartpeg-type-62-100545",
        "model_reference": "100545",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 68",
        "url": "https://devicerts.com/devices/smartpeg-type-68-100560",
        "model_reference": "100560",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 83",
        "url": "https://devicerts.com/devices/smartpeg-type-83-100714",
        "model_reference": "100714",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 23",
        "url": "https://devicerts.com/devices/smartpeg-type-23-100411",
        "model_reference": "100411",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 54",
        "url": "https://devicerts.com/devices/smartpeg-type-54-100485",
        "model_reference": "100485",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 26",
        "url": "https://devicerts.com/devices/smartpeg-type-26-100425",
        "model_reference": "100425",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 14",
        "url": "https://devicerts.com/devices/smartpeg-type-14-100374",
        "model_reference": "100374",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 60",
        "url": "https://devicerts.com/devices/smartpeg-type-60-100543",
        "model_reference": "100543",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 107 MegaGen",
        "url": "https://devicerts.com/devices/smartpeg-type-107-megagen-100744",
        "model_reference": "100744",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 119R",
        "url": "https://devicerts.com/devices/smartpeg-type-119r-08086519",
        "model_reference": "08086519",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 16",
        "url": "https://devicerts.com/devices/smartpeg-type-16-100388",
        "model_reference": "100388",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 76",
        "url": "https://devicerts.com/devices/smartpeg-type-76-100582",
        "model_reference": "100582",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 15",
        "url": "https://devicerts.com/devices/smartpeg-type-15-100386",
        "model_reference": "100386",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 31",
        "url": "https://devicerts.com/devices/smartpeg-type-31-100438",
        "model_reference": "100438",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 91",
        "url": "https://devicerts.com/devices/smartpeg-type-91-100750",
        "model_reference": "100750",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 33",
        "url": "https://devicerts.com/devices/smartpeg-type-33-100442",
        "model_reference": "100442",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 51",
        "url": "https://devicerts.com/devices/smartpeg-type-51-100482",
        "model_reference": "100482",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 112",
        "url": "https://devicerts.com/devices/smartpeg-type-112-08086144",
        "model_reference": "08086144",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 027R",
        "url": "https://devicerts.com/devices/smartpeg-type-027r-08086427",
        "model_reference": "08086427",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Osstell Isq Implant Stability Meter",
        "url": "https://devicerts.com/devices/osstell-isq-implant-stability-meter-ekx",
        "model_reference": "K082523",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-09-26",
        "open_recall": false
      },
      {
        "name": "Mega Isq",
        "url": "https://devicerts.com/devices/mega-isq-ekx",
        "model_reference": "K132401",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2014-04-09",
        "open_recall": false
      },
      {
        "name": "Osstell Beacon",
        "url": "https://devicerts.com/devices/osstell-beacon-ekx",
        "model_reference": "K181888",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2019-08-22",
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 96",
        "url": "https://devicerts.com/devices/smartpeg-type-96-100759",
        "model_reference": "100759",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 053R",
        "url": "https://devicerts.com/devices/smartpeg-type-053r-08086453",
        "model_reference": "08086453",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 01",
        "url": "https://devicerts.com/devices/smartpeg-type-01-100353",
        "model_reference": "100353",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 99",
        "url": "https://devicerts.com/devices/smartpeg-type-99-100764",
        "model_reference": "100764",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 49",
        "url": "https://devicerts.com/devices/smartpeg-type-49-100480",
        "model_reference": "100480",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SmartPeg Type 55",
        "url": "https://devicerts.com/devices/smartpeg-type-55-100487",
        "model_reference": "100487",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}