{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Setmark Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/setmark-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/setmark-inc",
    "json_url": "https://devicerts.com/manufacturers/setmark-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/setmark-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "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": null,
    "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/setmark-inc",
    "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": "Setmark Inc.",
    "url": "https://devicerts.com/manufacturers/setmark-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from the FDA registration address",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3009688852"
      },
      {
        "label": "DUNS",
        "value": "080798558"
      }
    ],
    "summary": "Setmark Inc. is a medical device manufacturer, with 42 devices listed in FDA GUDID (FDA Class I and II) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 42,
    "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": 42
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class I",
        "devices": 37
      },
      {
        "class": "FDA Class II",
        "devices": 5
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 42,
    "total": 42,
    "all_devices_url": "https://devicerts.com/manufacturers/setmark-inc",
    "items": [
      {
        "name": "Setmark Inc. ST-103",
        "url": "https://devicerts.com/devices/setmark-inc-st-103",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Inc. SS-107",
        "url": "https://devicerts.com/devices/setmark-inc-ss-107",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Inc. SS-100H",
        "url": "https://devicerts.com/devices/setmark-inc-ss-100h",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated TR-135",
        "url": "https://devicerts.com/devices/setmark-incorporated-tr-135",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark DC-100",
        "url": "https://devicerts.com/devices/setmark-dc-100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-101",
        "url": "https://devicerts.com/devices/setmark-ss-101",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-110",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-110",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-117",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-117",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-102",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-102",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-116",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-116",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Inc. NF300/627710",
        "url": "https://devicerts.com/devices/setmark-inc-nf300-627710",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-102",
        "url": "https://devicerts.com/devices/setmark-ss-102",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated TR-102",
        "url": "https://devicerts.com/devices/setmark-incorporated-tr-102",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated TR-136",
        "url": "https://devicerts.com/devices/setmark-incorporated-tr-136",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-111",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-111",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WA-175",
        "url": "https://devicerts.com/devices/setmark-incorporated-wa-175",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark DC-104",
        "url": "https://devicerts.com/devices/setmark-dc-104",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-109",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-109",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-106",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-106",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Inc. DC-108",
        "url": "https://devicerts.com/devices/setmark-inc-dc-108",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated TR-148",
        "url": "https://devicerts.com/devices/setmark-incorporated-tr-148",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated TR-103A",
        "url": "https://devicerts.com/devices/setmark-incorporated-tr-103a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-100",
        "url": "https://devicerts.com/devices/setmark-ss-100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-105",
        "url": "https://devicerts.com/devices/setmark-ss-105",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-105",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-105",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark DC-102",
        "url": "https://devicerts.com/devices/setmark-dc-102",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-104",
        "url": "https://devicerts.com/devices/setmark-ss-104",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-102",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-102",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-104B",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-104b",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-104",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-104",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark DC-103",
        "url": "https://devicerts.com/devices/setmark-dc-103",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-115",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-115",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-103",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-103",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WA-176",
        "url": "https://devicerts.com/devices/setmark-incorporated-wa-176",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WA-100",
        "url": "https://devicerts.com/devices/setmark-incorporated-wa-100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WA-111",
        "url": "https://devicerts.com/devices/setmark-incorporated-wa-111",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated NF-100",
        "url": "https://devicerts.com/devices/setmark-incorporated-nf-100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-105",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-105",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark DC-101",
        "url": "https://devicerts.com/devices/setmark-dc-101",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC-101",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc-101",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark SS-103",
        "url": "https://devicerts.com/devices/setmark-ss-103",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Setmark Incorporated WC103B",
        "url": "https://devicerts.com/devices/setmark-incorporated-wc103b",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}