{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Bionix, LLC. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bionix-llc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/bionix-llc",
    "json_url": "https://devicerts.com/manufacturers/bionix-llc.json",
    "markdown_url": "https://devicerts.com/manufacturers/bionix-llc.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": "2026-11-15",
    "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/bionix-llc",
    "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": "Bionix, LLC",
    "url": "https://devicerts.com/manufacturers/bionix-llc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Bionix Corp."
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000020408"
      },
      {
        "label": "FDA FEI",
        "value": "1526854"
      },
      {
        "label": "DUNS",
        "value": "117844489"
      }
    ],
    "summary": "Bionix, LLC is a medical device manufacturer based in the United States, with 220 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 220,
    "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": 218
      },
      {
        "registry": "EUDAMED",
        "devices": 67
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class I",
        "devices": 96
      },
      {
        "class": "FDA Class II",
        "devices": 65
      },
      {
        "class": "EU Class I",
        "devices": 59
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Q03",
        "name": "ENT devices",
        "url": "https://devicerts.com/categories/emdn/Q03",
        "devices": 39
      },
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 11
      },
      {
        "code": "V90",
        "name": "Various devices not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V90",
        "devices": 8
      },
      {
        "code": "A06",
        "name": "Drainage and fluids collection devices",
        "url": "https://devicerts.com/categories/emdn/A06",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Obelis S.A.",
        "url": "https://devicerts.com/representatives/obelis-sa-be-ar-000000106",
        "country": "Belgium"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 220,
    "all_devices_url": "https://devicerts.com/manufacturers/bionix-llc",
    "items": [
      {
        "name": "Microsuction Replacement Pack 2651",
        "url": "https://devicerts.com/devices/microsuction-replacement-pack-2651-ls-02651",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Magnetic Foreign Body Removal Tool 3525",
        "url": "https://devicerts.com/devices/lighted-magnetic-foreign-body-removal-tool-3525",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rechargeable Light Source 3600",
        "url": "https://devicerts.com/devices/rechargeable-light-source-3600-dcf821d5",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearLook Variety Pack with Rechargeable Light Source 3645",
        "url": "https://devicerts.com/devices/clearlook-variety-pack-with-rechargeable-light-source-3645",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearLook CeraSpoon 3350",
        "url": "https://devicerts.com/devices/clearlook-ceraspoon-3350",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearLook LEC, Sample Pack-Curettes Only 23300",
        "url": "https://devicerts.com/devices/clearlook-lec-sample-pack-curettes-only-23300",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearLook Variety, 50ct Refill Pack 3445",
        "url": "https://devicerts.com/devices/clearlook-variety-50ct-refill-pack-3445",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Magnetic Foreign Body Removal Tool 3521",
        "url": "https://devicerts.com/devices/lighted-magnetic-foreign-body-removal-tool-3521",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearLook CeraSpoon, 50ct Refill Pack 3450",
        "url": "https://devicerts.com/devices/clearlook-ceraspoon-50ct-refill-pack-3450",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Ear Curette",
        "url": "https://devicerts.com/devices/lighted-ear-curette-2512",
        "model_reference": "2512",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Ear Curette",
        "url": "https://devicerts.com/devices/lighted-ear-curette-3345-e096db1b",
        "model_reference": "3345",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pelvis Belly Large Abdominal Insert PPRT-5106",
        "url": "https://devicerts.com/devices/pelvis-belly-large-abdominal-insert-pprt-5106",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Placement Tool 2850",
        "url": "https://devicerts.com/devices/lighted-placement-tool-2850",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prone Breast System PBRT-6025-03",
        "url": "https://devicerts.com/devices/prone-breast-system-pbrt-6025-03",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureVac™ Immobilization System SVRT-7915",
        "url": "https://devicerts.com/devices/securevac-immobilization-system-svrt-7915",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Preemie Transport Blanket 21125",
        "url": "https://devicerts.com/devices/preemie-transport-blanket-21125",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SafeStraw™ Drinking Aid for Thin Liquid 202",
        "url": "https://devicerts.com/devices/safestraw-drinking-aid-for-thin-liquid-202",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement PBRT-6302",
        "url": "https://devicerts.com/devices/prone-breast-hardware-kit-head-rest-push-button-assembly-rep-pbrt-6302",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sample, Lighted FlexLoop 22205",
        "url": "https://devicerts.com/devices/sample-lighted-flexloop-22205",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureVac™ Immobilization System SVRT-7600",
        "url": "https://devicerts.com/devices/securevac-immobilization-system-svrt-7600",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureVac™ Immobilization System SVRT-7820-A",
        "url": "https://devicerts.com/devices/securevac-immobilization-system-svrt-7820-a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureVac™ Immobilization System SVRT-7625",
        "url": "https://devicerts.com/devices/securevac-immobilization-system-svrt-7625",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Opti-Tatt™ Field Borders UTRT-4300",
        "url": "https://devicerts.com/devices/opti-tatt-field-borders-utrt-4300",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureFoam 25038",
        "url": "https://devicerts.com/devices/securefoam-25038",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "IsoMark™ UTRT-3101",
        "url": "https://devicerts.com/devices/isomark-3101-5d5fbbe6",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureFoam 5038",
        "url": "https://devicerts.com/devices/securefoam-5038-50c16cad",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OtoClear SprayWash Adapter Wand 27219",
        "url": "https://devicerts.com/devices/otoclear-spraywash-adapter-wand-27219",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ear Wax Removal Kit 702",
        "url": "https://devicerts.com/devices/ear-wax-removal-kit-702",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureFoam 5036",
        "url": "https://devicerts.com/devices/securefoam-5036-3f342c2b",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Articulating - Sample 22511",
        "url": "https://devicerts.com/devices/lighted-articulating-sample-22511",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bionix, LLC UTRT-3105",
        "url": "https://devicerts.com/devices/bionix-llc-3105",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sample, Lighted Suction Handle 22625",
        "url": "https://devicerts.com/devices/sample-lighted-suction-handle-22625",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bionix, LLC UTRT-3100",
        "url": "https://devicerts.com/devices/bionix-llc-3100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Ear Curette Demo Pack (monthly mailer) 22201",
        "url": "https://devicerts.com/devices/lighted-ear-curette-demo-pack-monthly-mailer-22201",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Igloo Wound Irrigator 25000",
        "url": "https://devicerts.com/devices/igloo-wound-irrigator-25000",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lighted Microsuction System 2650",
        "url": "https://devicerts.com/devices/microsuction-stater-pack-ls-02650",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bionix Development Corporation Sp-20913",
        "url": "https://devicerts.com/devices/bionix-development-corporation-20913",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureVac™ Immobilization System SVRT-7133",
        "url": "https://devicerts.com/devices/securevac-immobilization-system-svrt-7133",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Swaddler for Phototherapy 1100",
        "url": "https://devicerts.com/devices/swaddler-for-phototherapy-1100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "27247 Sp-27247",
        "url": "https://devicerts.com/devices/sample-otoclear-r-ear-irrigation-system-220v-27247",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sample, Lighted Forceps for Foreign Body Removal SP-22750",
        "url": "https://devicerts.com/devices/sample-lighted-forceps-for-foreign-body-removal-22750",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SafeStraw 1510",
        "url": "https://devicerts.com/devices/safestraw-1510",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SecureFoam 5037",
        "url": "https://devicerts.com/devices/securefoam-5037-3de0a86c",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AfterSwim 530",
        "url": "https://devicerts.com/devices/afterswim-530",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OtoClear Tip Sample 27230",
        "url": "https://devicerts.com/devices/otoclear-tip-sample-27230",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pelvis Belly Replacement Face Cushion Assembly PPRT-5107",
        "url": "https://devicerts.com/devices/pelvis-belly-replacement-face-cushion-assembly-pprt-5107",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "IsoMark™ UTRT-3102",
        "url": "https://devicerts.com/devices/isomark-3102",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pelvis Belly Replacement Arm Rest Cushion PPRT-5103",
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      {
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      {
        "name": "OtoClear SprayWash System, Single Use Sample 27291",
        "url": "https://devicerts.com/devices/otoclear-spraywash-system-single-use-sample-27291",
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  "certificates": [],
  "recalls": []
}