{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Pascal Company, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/pascal-company-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/pascal-company-inc",
    "json_url": "https://devicerts.com/manufacturers/pascal-company-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/pascal-company-inc.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 recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/pascal-company-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": "Pascal Company, Inc.",
    "url": "https://devicerts.com/manufacturers/pascal-company-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Pascal Co., Inc."
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000032036"
      },
      {
        "label": "DUNS",
        "value": "009260217"
      }
    ],
    "summary": "Pascal Company, Inc. is a medical device manufacturer based in the United States, with 170 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I; FDA Unclassified, Class I and Class II) and 1 FDA recall as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 170,
    "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": 134
      },
      {
        "registry": "EUDAMED",
        "devices": 104
      },
      {
        "registry": "FDA 510(k)",
        "devices": 8
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 97
      },
      {
        "class": "FDA Unclassified",
        "devices": 39
      },
      {
        "class": "FDA Class I",
        "devices": 23
      },
      {
        "class": "FDA Class II",
        "devices": 11
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Q01",
        "name": "Dental devices",
        "url": "https://devicerts.com/categories/emdn/Q01",
        "devices": 85
      },
      {
        "code": "D08",
        "name": "Detergents for medical devices",
        "url": "https://devicerts.com/categories/emdn/D08",
        "devices": 4
      },
      {
        "code": "D01",
        "name": "Aldehydes for the disinfection of medical devices",
        "url": "https://devicerts.com/categories/emdn/D01",
        "devices": 2
      },
      {
        "code": "L03",
        "name": "General surgery instruments, reusable",
        "url": "https://devicerts.com/categories/emdn/L03",
        "devices": 2
      },
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 2
      },
      {
        "code": "L01",
        "name": "Sharp instruments, reusable",
        "url": "https://devicerts.com/categories/emdn/L01",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Emergo Europe B.V.",
        "url": "https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 170,
    "all_devices_url": "https://devicerts.com/manufacturers/pascal-company-inc",
    "items": [
      {
        "name": "ProPak 000",
        "url": "https://devicerts.com/devices/propak-000-07496",
        "model_reference": "07496",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hydent, French",
        "url": "https://devicerts.com/devices/hydent-french-05101",
        "model_reference": "05101",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ProPak 01",
        "url": "https://devicerts.com/devices/propak-01-07510",
        "model_reference": "07510",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ProPak 00",
        "url": "https://devicerts.com/devices/propak-00-07497",
        "model_reference": "07497",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ProPak 0",
        "url": "https://devicerts.com/devices/propak-0-07500",
        "model_reference": "07500",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Hydent Sticks, French",
        "url": "https://devicerts.com/devices/hydent-sticks-french-05111",
        "model_reference": "05111",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PT-55, Blue",
        "url": "https://devicerts.com/devices/pt-55-blue-26136",
        "model_reference": "26136",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ProPak 02",
        "url": "https://devicerts.com/devices/propak-02-07520",
        "model_reference": "07520",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PT-55, Green",
        "url": "https://devicerts.com/devices/pt-55-green-26138",
        "model_reference": "26138",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PT-55, Pink",
        "url": "https://devicerts.com/devices/pt-55-pink-26137",
        "model_reference": "26137",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pick Pack",
        "url": "https://devicerts.com/devices/pick-pack-26210-dad9be55",
        "model_reference": "26210",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste, Medium Grit, Bubblegum Flavor Jar 13650",
        "url": "https://devicerts.com/devices/radent-prophy-paste-medium-grit-bubblegum-flavor-jar-13650",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Two Retraction Cord 7/00 07797",
        "url": "https://devicerts.com/devices/racord-two-retraction-cord-7-00-07797",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gel Cord Clear Topical Hemostatic Gel ProPack 15840",
        "url": "https://devicerts.com/devices/gel-cord-clear-topical-hemostatic-gel-propack-15840",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Two Retraction Cord 10/2 07820",
        "url": "https://devicerts.com/devices/racord-two-retraction-cord-10-2-07820",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gel Cord Topical Hemostatic Gel ProPack 15540",
        "url": "https://devicerts.com/devices/gel-cord-topical-hemostatic-gel-propack-15540",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Epidri Pellets 12100",
        "url": "https://devicerts.com/devices/epidri-pellets-12100",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Retraction Cord 07/00 07697",
        "url": "https://devicerts.com/devices/racord-retraction-cord-07-00-07697",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fluorilaq Salted Caramel (10mL) Tube 10402",
        "url": "https://devicerts.com/devices/fluorilaq-salted-caramel-10ml-tube-10402",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste Cups, Fine Grit, Cotton Candy for Kids 13260",
        "url": "https://devicerts.com/devices/radent-prophy-paste-cups-fine-grit-cotton-candy-for-kids-13260",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kois Kr-4 Packer 26228",
        "url": "https://devicerts.com/devices/kois-kr-4-packer-26228",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Retrax Solution 15 mL 15600",
        "url": "https://devicerts.com/devices/retrax-solution-15-ml-15600",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax Plus Retraction Cord 7/00 07297",
        "url": "https://devicerts.com/devices/siltrax-plus-retraction-cord-7-00-07297",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Retraction Cord 8/0 07700",
        "url": "https://devicerts.com/devices/racord-retraction-cord-8-0-07700",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax EPI Retraction Cord 7/00 07197",
        "url": "https://devicerts.com/devices/siltrax-epi-retraction-cord-7-00-07197",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kois Kr-5 Packer 26229",
        "url": "https://devicerts.com/devices/kois-kr-5-packer-26229",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kois Kr-3 Packer 26227",
        "url": "https://devicerts.com/devices/kois-kr-3-packer-26227",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fluorilaq Squeeze Varnish Bubblegum 10420",
        "url": "https://devicerts.com/devices/fluorilaq-squeeze-varnish-bubblegum-10420",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste Medium Grit Strawberry Jar 13800",
        "url": "https://devicerts.com/devices/radent-prophy-paste-medium-grit-strawberry-jar-13800",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Plus Retraction Cord 9/1 07810",
        "url": "https://devicerts.com/devices/racord-plus-retraction-cord-9-1-07810",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Stat Gel Topical Hemostatic Gel ProPack 15740",
        "url": "https://devicerts.com/devices/stat-gel-topical-hemostatic-gel-propack-15740",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste Cups, Medium, Fresh Mint 13200",
        "url": "https://devicerts.com/devices/radent-prophy-paste-cups-medium-fresh-mint-13200",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Get Sculpted 26-310",
        "url": "https://devicerts.com/devices/get-sculpted-26-310",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fluorilaq Squeeze Varnish Salted Caramel 10425",
        "url": "https://devicerts.com/devices/fluorilaq-squeeze-varnish-salted-caramel-10425",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax AS Retraction Cord 10/2 07120",
        "url": "https://devicerts.com/devices/siltrax-as-retraction-cord-10-2-07120",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Contra Angle 22200",
        "url": "https://devicerts.com/devices/contra-angle-22200",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Two Retraction Cord 9/1 07810",
        "url": "https://devicerts.com/devices/racord-two-retraction-cord-9-1-07810",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax EPI Retraction Cord 9/1 07210",
        "url": "https://devicerts.com/devices/siltrax-epi-retraction-cord-9-1-07210",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fluorilaq Varnish Bubblegum 10400",
        "url": "https://devicerts.com/devices/fluorilaq-varnish-bubblegum-10400",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racellet 3 Pellets 12200",
        "url": "https://devicerts.com/devices/racellet-3-pellets-12200",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Retrax Gel FS ProPack 15740",
        "url": "https://devicerts.com/devices/retrax-gel-fs-propack-15740",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Plus Retraction Cord 10/2 07820",
        "url": "https://devicerts.com/devices/racord-plus-retraction-cord-10-2-07820",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste Medium Grit Cherry Jar 13700",
        "url": "https://devicerts.com/devices/radent-prophy-paste-medium-grit-cherry-jar-13700",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax AS Retraction Cord 9/1 07110",
        "url": "https://devicerts.com/devices/siltrax-as-retraction-cord-9-1-07110",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Retraction Cord 10/2 07720",
        "url": "https://devicerts.com/devices/racord-retraction-cord-10-2-07720",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fluorilaq Squeeze Varnish Fresh Mint 10435",
        "url": "https://devicerts.com/devices/fluorilaq-squeeze-varnish-fresh-mint-10435",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Racord Retraction Cord 9/1 07710",
        "url": "https://devicerts.com/devices/racord-retraction-cord-9-1-07710",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SilTrax EPI Retraction Cord 8/0 07200",
        "url": "https://devicerts.com/devices/siltrax-epi-retraction-cord-8-0-07200",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Radent Prophy Paste, Medium, Grit Mint Jar 13600",
        "url": "https://devicerts.com/devices/radent-prophy-paste-medium-grit-mint-jar-13600",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gel Cord Topical Hemostatic Gel MicroPoints 15505",
        "url": "https://devicerts.com/devices/gel-cord-topical-hemostatic-gel-micropoints-15505",
        "model_reference": null,
        "device_class": "Unclassified",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1588-05",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2005-08-09",
      "product_code": "MED",
      "reason": "The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use."
    }
  ]
}