{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Biotex, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/biotex-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/biotex-inc",
    "json_url": "https://devicerts.com/manufacturers/biotex-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/biotex-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"
      }
    ],
    "eudamed_record_synced": null,
    "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/biotex-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": "Biotex, Inc.",
    "url": "https://devicerts.com/manufacturers/biotex-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3005726841"
      },
      {
        "label": "DUNS",
        "value": "969792050"
      }
    ],
    "summary": "Biotex, Inc. is a medical device manufacturer, with 41 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 41,
    "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": 31
      },
      {
        "registry": "FDA 510(k)",
        "devices": 10
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 27
      },
      {
        "class": "FDA Class I",
        "devices": 14
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 41,
    "total": 41,
    "all_devices_url": "https://devicerts.com/manufacturers/biotex-inc",
    "items": [
      {
        "name": "Bayou™ troCarWash System Disposable Kit TCW-5-100",
        "url": "https://devicerts.com/devices/bayou-trocarwash-system-disposable-kit-tcw-5-100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OcciGuide 048-1000",
        "url": "https://devicerts.com/devices/occiguide-er-guide-1010",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bayou™ troCarWash System Disposable Kit 038-1000",
        "url": "https://devicerts.com/devices/bayou-trocarwash-system-disposable-kit-038-1000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1042",
        "url": "https://devicerts.com/devices/phasor-drill-ph-635-70",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safe-Cam Sterile Video Stylet 033-1000",
        "url": "https://devicerts.com/devices/safe-cam-sterile-video-stylet-sc-vs",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1045",
        "url": "https://devicerts.com/devices/phasor-drill-ph-450-70",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OcciGuide 048-1001",
        "url": "https://devicerts.com/devices/occiguide-er-guide-1005",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Wire Watch™ WW-1D",
        "url": "https://devicerts.com/devices/wire-watch-ww-1d",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Wire Watch™ WW-12K",
        "url": "https://devicerts.com/devices/wire-watch-ww-12k",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safe-Cam Display Monitor Charger 033-6000-003",
        "url": "https://devicerts.com/devices/safe-cam-display-monitor-charger-sc-mr",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1044",
        "url": "https://devicerts.com/devices/phasor-drill-ph-530-70",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safe-Cam Tablet and Accessories 033-5000",
        "url": "https://devicerts.com/devices/safe-cam-tablet-and-accessories-sc-ndk",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SurgiLux™ SL-12",
        "url": "https://devicerts.com/devices/surgilux-sl-12",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1046",
        "url": "https://devicerts.com/devices/phasor-drill-ph-250-210",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safe-Cam Display Monitor Assembly 033-6501",
        "url": "https://devicerts.com/devices/safe-cam-display-monitor-assembly-sc-m",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safe-Cam Connecting Cable Assembly 033-6500",
        "url": "https://devicerts.com/devices/safe-cam-connecting-cable-assembly-sc-c",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Wire Watch™ 021-1001",
        "url": "https://devicerts.com/devices/wire-watch-021-1001",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The Slide® 046-1000",
        "url": "https://devicerts.com/devices/the-slide-r-046-1000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1050",
        "url": "https://devicerts.com/devices/phasor-drill-ph-240-70",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bayou™ troCarWash System Controller TCW-C",
        "url": "https://devicerts.com/devices/bayou-trocarwash-system-controller-tcw-c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 1",
        "url": "https://devicerts.com/devices/phasor-drill-1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Slide Bite Fork 046-1400",
        "url": "https://devicerts.com/devices/slide-bite-fork-046-1400",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bayou™ troCarWash System Controller 038-5000",
        "url": "https://devicerts.com/devices/bayou-trocarwash-system-controller-038-5000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1011",
        "url": "https://devicerts.com/devices/phasor-drill-ph-320-210",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The Slide® 046-1500",
        "url": "https://devicerts.com/devices/the-slide-r-046-1500",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bayou™ troCarWash System Disposable Kit TCW-10-120",
        "url": "https://devicerts.com/devices/bayou-trocarwash-system-disposable-kit-tcw-10-120",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1049",
        "url": "https://devicerts.com/devices/phasor-drill-ph-240-210",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1048",
        "url": "https://devicerts.com/devices/phasor-drill-ph-270-210",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1047",
        "url": "https://devicerts.com/devices/phasor-drill-ph-270-70",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Phasor Drill 008-1043",
        "url": "https://devicerts.com/devices/phasor-drill-ph-580-70",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OcciGuide ER GUIDE 1010",
        "url": "https://devicerts.com/devices/occiguide-048-1000",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Visualase Envision Software System",
        "url": "https://devicerts.com/devices/visualase-envision-software-system-llz",
        "model_reference": "K063505",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-12-12",
        "open_recall": false
      },
      {
        "name": "troCarWash™ System",
        "url": "https://devicerts.com/devices/trocarwash-system-ocx-k233442",
        "model_reference": "K233442",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2024-05-21",
        "open_recall": false
      },
      {
        "name": "PHOTEX30 Diode Laser Series: 980, 810, 940",
        "url": "https://devicerts.com/devices/photex30-diode-laser-series-980-810-940-gex",
        "model_reference": "K092197",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2009-10-06",
        "open_recall": false
      },
      {
        "name": "The Slide",
        "url": "https://devicerts.com/devices/the-slide-lqz",
        "model_reference": "K203712",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2021-07-20",
        "open_recall": false
      },
      {
        "name": "Visualase Thermal Therapy System",
        "url": "https://devicerts.com/devices/visualase-thermal-therapy-system-gex",
        "model_reference": "K071328",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2007-08-31",
        "open_recall": false
      },
      {
        "name": "Photex Diode Laser Series, Models 980, 810 And 940",
        "url": "https://devicerts.com/devices/photex-diode-laser-series-models-980-810-and-940-gex",
        "model_reference": "K060304",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-03-21",
        "open_recall": false
      },
      {
        "name": "Visualase Thermal Therapy System",
        "url": "https://devicerts.com/devices/visualase-thermal-therapy-system-llz",
        "model_reference": "K081656",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-09-10",
        "open_recall": false
      },
      {
        "name": "troCarWash™ System",
        "url": "https://devicerts.com/devices/trocarwash-system-ocx",
        "model_reference": "K222695",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2023-02-17",
        "open_recall": false
      },
      {
        "name": "Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System",
        "url": "https://devicerts.com/devices/visualase-cooled-laser-applicator-system-laser-diffusing-fib-gex",
        "model_reference": "K053087",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-03-01",
        "open_recall": true
      },
      {
        "name": "Phasor Drill",
        "url": "https://devicerts.com/devices/phasor-drill-hbe",
        "model_reference": "K161704",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2016-12-01",
        "open_recall": true
      }
    ]
  },
  "certificates": [],
  "recalls": []
}