{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "B&L Biotech. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bl-biotech (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/bl-biotech",
    "json_url": "https://devicerts.com/manufacturers/bl-biotech.json",
    "markdown_url": "https://devicerts.com/manufacturers/bl-biotech.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 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/bl-biotech",
    "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": "B&L Biotech",
    "url": "https://devicerts.com/manufacturers/bl-biotech",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "B&L BIOTECH CO., INC"
    ],
    "country": "South Korea",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "KR-MF-000023296"
      }
    ],
    "summary": "B&L Biotech is a medical device manufacturer based in South Korea, with 217 devices listed in EUDAMED and FDA GUDID (EU Class I and IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 217,
    "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": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 217
      },
      {
        "registry": "FDA GUDID",
        "devices": 202
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 157
      },
      {
        "class": "EU Class IIa",
        "devices": 60
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Q01",
        "name": "Dental devices",
        "url": "https://devicerts.com/categories/emdn/Q01",
        "devices": 137
      },
      {
        "code": "L15",
        "name": "Odontostomatology instruments, reusable",
        "url": "https://devicerts.com/categories/emdn/L15",
        "devices": 46
      },
      {
        "code": "V03",
        "name": "Measurement devices",
        "url": "https://devicerts.com/categories/emdn/V03",
        "devices": 29
      },
      {
        "code": "L16",
        "name": "Diagnostic instruments, reusable",
        "url": "https://devicerts.com/categories/emdn/L16",
        "devices": 5
      }
    ]
  },
  "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": 217,
    "all_devices_url": "https://devicerts.com/manufacturers/bl-biotech",
    "items": [
      {
        "name": "Sprds",
        "url": "https://devicerts.com/devices/sprds-sprds",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sprdn",
        "url": "https://devicerts.com/devices/sprdn-sprdn",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leetrac",
        "url": "https://devicerts.com/devices/leetrac-leetrac-ed74713c",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leetrac",
        "url": "https://devicerts.com/devices/leetrac-leetrac",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2123",
        "url": "https://devicerts.com/devices/bsn2123-bp-b1-96885b8d",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BMN2425",
        "url": "https://devicerts.com/devices/bmn2425-bp-b1-398dce39",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2225",
        "url": "https://devicerts.com/devices/bsn2225-bp-b1-14792a5f",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Is Tip",
        "url": "https://devicerts.com/devices/is-tip-19110477",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pomo",
        "url": "https://devicerts.com/devices/pomo-19110651",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endo B",
        "url": "https://devicerts.com/devices/endo-b-19140696",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BP6012",
        "url": "https://devicerts.com/devices/bp6012-cl-a1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Jetip",
        "url": "https://devicerts.com/devices/jetip-19110392",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2225",
        "url": "https://devicerts.com/devices/bsn2225-bp-b1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2425",
        "url": "https://devicerts.com/devices/bsn2425-bp-b1-93823aab",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments Micro Mirror",
        "url": "https://devicerts.com/devices/jetip-instruments-micro-mirror-19115465",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BMN2425",
        "url": "https://devicerts.com/devices/bmn2425-bp-b1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kimtrac",
        "url": "https://devicerts.com/devices/kimtrac-19111153",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endo B",
        "url": "https://devicerts.com/devices/endo-b-19140771",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BP4004",
        "url": "https://devicerts.com/devices/bp4004-cl-a1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-jibh",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Is Tip",
        "url": "https://devicerts.com/devices/is-tip-19110446",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Beta Mini",
        "url": "https://devicerts.com/devices/beta-mini-bp-b1-bb3d1e6f",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bl Tip",
        "url": "https://devicerts.com/devices/bl-tip-19110279",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BMN2423",
        "url": "https://devicerts.com/devices/bmn2423-bp-b1-bf74a6ec",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BL-S Kondenser",
        "url": "https://devicerts.com/devices/bl-s-kondenser-19110064",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2420",
        "url": "https://devicerts.com/devices/bsn2420-bp-b1-35138d26",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-19115151",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-jb2",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BMN2420",
        "url": "https://devicerts.com/devices/bmn2420-bp-b1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kimtrac",
        "url": "https://devicerts.com/devices/kimtrac-ktnnh",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2820",
        "url": "https://devicerts.com/devices/bsn2028-bp-b1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Jetip",
        "url": "https://devicerts.com/devices/jetip-19110385",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endo R",
        "url": "https://devicerts.com/devices/endo-r-19140122",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BL-S Kondenser",
        "url": "https://devicerts.com/devices/bl-s-kondenser-19110088",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Como",
        "url": "https://devicerts.com/devices/como-19111337",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endo M&R",
        "url": "https://devicerts.com/devices/endo-mandr-enmssgrlg-r",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "B&L GP Gauge&Cutter",
        "url": "https://devicerts.com/devices/bandl-gp-gaugeandcutter-ggac",
        "model_reference": "GGAC",
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kimtrac",
        "url": "https://devicerts.com/devices/kimtrac-19111184",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BL-B Kondenser",
        "url": "https://devicerts.com/devices/bl-b-kondenser-19110118",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BP5506",
        "url": "https://devicerts.com/devices/bp5506-cl-a1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-19115045",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Endo B",
        "url": "https://devicerts.com/devices/endo-b-19140795",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kimtrac",
        "url": "https://devicerts.com/devices/kimtrac-ktrp2n",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-jpp",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leetrac",
        "url": "https://devicerts.com/devices/leetrac-19110958",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Leetrac",
        "url": "https://devicerts.com/devices/leetrac-ltsbs",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vibrapost",
        "url": "https://devicerts.com/devices/vibrapost-19110286",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "JETIP Instruments",
        "url": "https://devicerts.com/devices/jetip-instruments-19115038",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BSN2425",
        "url": "https://devicerts.com/devices/bsn2425-bp-b1",
        "model_reference": null,
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "BL-B Kondenser",
        "url": "https://devicerts.com/devices/bl-b-kondenser-19110125",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}