{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Biotech Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/biotech-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/biotech-inc",
    "json_url": "https://devicerts.com/manufacturers/biotech-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/biotech-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/"
      }
    ],
    "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/biotech-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": "Biotech Inc",
    "url": "https://devicerts.com/manufacturers/biotech-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Bio-Tech Co."
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer",
      "Part of a group"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000002378"
      }
    ],
    "summary": "Biotech Inc is a medical device manufacturer based in the United States, with 20 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 20,
    "devices_note": null,
    "certificates": 1,
    "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": 17
      },
      {
        "registry": "EUDAMED",
        "devices": 2
      },
      {
        "registry": "FDA 510(k)",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 17
      },
      {
        "class": "EU Class IIa",
        "devices": 2
      },
      {
        "class": "FDA Class I",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "U08",
        "name": "Gynaecological devices",
        "url": "https://devicerts.com/categories/emdn/U08",
        "devices": 2
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "Biotech GmbH",
      "url": "https://devicerts.com/manufacturers/biotech-gmbh"
    },
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Atlantico Systems, Ltd.",
        "url": "https://devicerts.com/representatives/atlantico-systems-ltd-ie-ar-000000208",
        "country": "Ireland"
      }
    ]
  },
  "devices": {
    "shown": 20,
    "total": 20,
    "all_devices_url": "https://devicerts.com/manufacturers/biotech-inc",
    "items": [
      {
        "name": "Cryolock(Lg) Cl-R-Ct(Lg)",
        "url": "https://devicerts.com/devices/cryolock-lg-cl-r-ct-lg-cl-r-ct-lime-green",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(Pk) Cl-R-Ct(Pk)",
        "url": "https://devicerts.com/devices/cryolock-pk-cl-r-ct-pk-cl-r-ct-pink",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(Pr) Cl-R-Ct(Pr)",
        "url": "https://devicerts.com/devices/cryolock-pr-cl-r-ct-pr-cl-r-ct-purple",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock(Lg) S-Cl(Lg)",
        "url": "https://devicerts.com/devices/s-cryolock-lg-s-cl-lg-s-cl-lime-green",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (Pk) S-Cl (Pk)",
        "url": "https://devicerts.com/devices/s-cryolock-pk-s-cl-pk-s-cl-pink",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (Pr) S-Cl (Pr)",
        "url": "https://devicerts.com/devices/s-cryolock-pr-s-cl-pr-s-cl-purple",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(O) Cl-R-Ct(O)",
        "url": "https://devicerts.com/devices/cryolock-o-cl-r-ct-orange",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (G) S-Cl (G)",
        "url": "https://devicerts.com/devices/s-cryolock-g-s-cl-green",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(G) CL-R-CT(G)",
        "url": "https://devicerts.com/devices/cryolock-g-cl-r-ct-green",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(Y) Cl-R-Ct(Y)",
        "url": "https://devicerts.com/devices/cryolock-y-cl-r-ct-yellow",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (O) S-Cl (O)",
        "url": "https://devicerts.com/devices/s-cryolock-o-s-cl-orange",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (Y) S-Cl (Y)",
        "url": "https://devicerts.com/devices/s-cryolock-y-s-cl-yellow",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(C) Cl-R-Ct(C)",
        "url": "https://devicerts.com/devices/cryolock-c-cl-r-ct-clear",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Cryolock(B) CL-R-CT(B)",
        "url": "https://devicerts.com/devices/cryolock-b-cl-r-ct-blue",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (B) S-Cl (B)",
        "url": "https://devicerts.com/devices/s-cryolock-b-s-cl-blue",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock (C) S-Cl (C)",
        "url": "https://devicerts.com/devices/s-cryolock-c-s-cl-clear",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fx-Cablelok System",
        "url": "https://devicerts.com/devices/fx-cablelok-system-jdq-k922142",
        "model_reference": "K922142",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1992-11-20",
        "open_recall": false
      },
      {
        "name": "Consti-Ssage Vibrator/Massage",
        "url": "https://devicerts.com/devices/consti-ssage-vibrator-massage-isa",
        "model_reference": "K900674",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1990-03-02",
        "open_recall": false
      },
      {
        "name": "Cryolock",
        "url": "https://devicerts.com/devices/cryolock-cl-r-ct",
        "model_reference": "CL-R-CT",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "S-Cryolock",
        "url": "https://devicerts.com/devices/s-cryolock-s-cl",
        "model_reference": "S-CL",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "MDR 755826",
      "type": "Quality assurance",
      "legislation": "MDR",
      "notified_body": "BSI Group The Netherlands B.V.",
      "issued": "2022-11-09",
      "expires": "2027-11-08",
      "status": "issued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}