{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Andwin Scientific. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/andwin-scientific (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/andwin-scientific",
    "json_url": "https://devicerts.com/manufacturers/andwin-scientific.json",
    "markdown_url": "https://devicerts.com/manufacturers/andwin-scientific.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": "2026-11-15",
    "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/andwin-scientific",
    "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": "Andwin Scientific",
    "url": "https://devicerts.com/manufacturers/andwin-scientific",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from the FDA registration address",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "2027344"
      },
      {
        "label": "DUNS",
        "value": "028449445"
      }
    ],
    "summary": "Andwin Scientific is a medical device manufacturer, with 36 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 36,
    "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": 33
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 30
      },
      {
        "class": "FDA Class I",
        "devices": 6
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 36,
    "total": 36,
    "all_devices_url": "https://devicerts.com/manufacturers/andwin-scientific",
    "items": [
      {
        "name": "Andwin Scientific 231048",
        "url": "https://devicerts.com/devices/andwin-scientific-231048",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760020S",
        "url": "https://devicerts.com/devices/sealsafe-760020s",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230160",
        "url": "https://devicerts.com/devices/andwin-scientific-230160",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 892035",
        "url": "https://devicerts.com/devices/andwin-scientific-892035",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890183",
        "url": "https://devicerts.com/devices/andwin-scientific-890183",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Papette 892030",
        "url": "https://devicerts.com/devices/papette-892030-p100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 892033",
        "url": "https://devicerts.com/devices/andwin-scientific-892033",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760020P",
        "url": "https://devicerts.com/devices/sealsafe-760020p",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230110",
        "url": "https://devicerts.com/devices/andwin-scientific-230110",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760028P",
        "url": "https://devicerts.com/devices/sealsafe-760028p",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890187",
        "url": "https://devicerts.com/devices/andwin-scientific-890187",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230100",
        "url": "https://devicerts.com/devices/andwin-scientific-230100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230152",
        "url": "https://devicerts.com/devices/andwin-scientific-230152",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 240080",
        "url": "https://devicerts.com/devices/andwin-scientific-240080",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760024S",
        "url": "https://devicerts.com/devices/sealsafe-760024s",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230040",
        "url": "https://devicerts.com/devices/andwin-scientific-230040",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Papette 892030",
        "url": "https://devicerts.com/devices/papette-892030-p25",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890182",
        "url": "https://devicerts.com/devices/andwin-scientific-890182",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 210070",
        "url": "https://devicerts.com/devices/andwin-scientific-210070",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safetex 890076",
        "url": "https://devicerts.com/devices/safetex-890076",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin 890181",
        "url": "https://devicerts.com/devices/andwin-890181",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890185",
        "url": "https://devicerts.com/devices/andwin-scientific-890185",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230075",
        "url": "https://devicerts.com/devices/andwin-scientific-230075",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 892010",
        "url": "https://devicerts.com/devices/andwin-scientific-892010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230170",
        "url": "https://devicerts.com/devices/andwin-scientific-230170",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760028S",
        "url": "https://devicerts.com/devices/sealsafe-760028s",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230180",
        "url": "https://devicerts.com/devices/andwin-scientific-230180",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890186",
        "url": "https://devicerts.com/devices/andwin-scientific-890186",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Rovers 893010",
        "url": "https://devicerts.com/devices/rovers-893010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 230080",
        "url": "https://devicerts.com/devices/andwin-scientific-230080",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 231057",
        "url": "https://devicerts.com/devices/andwin-scientific-231057",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Andwin Scientific 890184",
        "url": "https://devicerts.com/devices/andwin-scientific-890184",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SealSafe 760024P",
        "url": "https://devicerts.com/devices/sealsafe-760024p",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Safetex Chlamydia Trachomatis Specimen Collection Kit",
        "url": "https://devicerts.com/devices/safetex-chlamydia-trachomatis-specimen-collection-kit-hht",
        "model_reference": "K983599",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-12-11",
        "open_recall": false
      },
      {
        "name": "Safetex Combination Blood (Alcohol, Ethyl) / Urine Collection And Transport Kit",
        "url": "https://devicerts.com/devices/safetex-combination-blood-alcohol-ethyl-urine-collection-and-jka",
        "model_reference": "K964698",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1997-03-03",
        "open_recall": false
      },
      {
        "name": "Safetex Cervical Scraper (Plastic)",
        "url": "https://devicerts.com/devices/safetex-cervical-scraper-plastic-hht",
        "model_reference": "K983428",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1998-11-16",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}