{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Groman Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/groman-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/groman-inc",
    "json_url": "https://devicerts.com/manufacturers/groman-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/groman-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "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"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/groman-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": "Groman Inc.",
    "url": "https://devicerts.com/manufacturers/groman-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": "3004361444"
      },
      {
        "label": "DUNS",
        "value": "020124663"
      }
    ],
    "summary": "Groman Inc. is a medical device manufacturer, with 22 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 22,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 1,
    "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": 21
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 19
      },
      {
        "class": "FDA Class I",
        "devices": 3
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 22,
    "total": 22,
    "all_devices_url": "https://devicerts.com/manufacturers/groman-inc",
    "items": [
      {
        "name": "Etchmaster EM-L-N-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-n-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster PM-X-L-RB",
        "url": "https://devicerts.com/devices/etchmaster-pm-x-l-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-O-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-o-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SafetyO2 AM-OXY-FP",
        "url": "https://devicerts.com/devices/safetyo2-am-oxy-fp",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-K-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-k-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-G-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-g-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-K-CA",
        "url": "https://devicerts.com/devices/etchmaster-em-l-k-ca",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-K-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-k-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-P-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-p-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-Y-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-y-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SafetyFilta GRO-SF-NEB-25",
        "url": "https://devicerts.com/devices/safetyfilta-gro-sf-neb-25",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SafetyNeb AM-NEB-FP",
        "url": "https://devicerts.com/devices/safetyneb-am-neb-fp",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-R-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-r-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-Y-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-y-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-F-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-f-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-K-CA",
        "url": "https://devicerts.com/devices/etchmaster-em-s-k-ca",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-R-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-r-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-G-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-g-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-L-B-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-l-b-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-J-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-j-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Etchmaster EM-S-B-RB",
        "url": "https://devicerts.com/devices/etchmaster-em-s-b-rb",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Groman Prepmaster",
        "url": "https://devicerts.com/devices/groman-prepmaster-koj",
        "model_reference": "K030292",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2003-04-15",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0742-2012",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2010-12-13",
      "product_code": "KOJ",
      "reason": "Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges."
    }
  ]
}