{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Biosystems S.A. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/biosystems-sa (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/biosystems-sa",
    "json_url": "https://devicerts.com/manufacturers/biosystems-sa.json",
    "markdown_url": "https://devicerts.com/manufacturers/biosystems-sa.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "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/biosystems-sa",
    "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": "Biosystems S.A.",
    "url": "https://devicerts.com/manufacturers/biosystems-sa",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Spain",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "ES-MF-000000231"
      }
    ],
    "summary": "Biosystems S.A. is a medical device manufacturer based in Spain, with 361 devices listed in EUDAMED and FDA 510(k) (EU IVD General, Class C and Class A; FDA Class II) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 361,
    "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": "EUDAMED",
        "devices": 358
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "EU IVD General",
        "devices": 290
      },
      {
        "class": "EU Class C",
        "devices": 39
      },
      {
        "class": "EU Class A",
        "devices": 29
      },
      {
        "class": "FDA Class II",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "W01",
        "name": "Reagents",
        "url": "https://devicerts.com/categories/emdn/W01",
        "devices": 336
      },
      {
        "code": "W02",
        "name": "IVD instruments",
        "url": "https://devicerts.com/categories/emdn/W02",
        "devices": 18
      },
      {
        "code": "W05",
        "name": "IVD generic use consumables",
        "url": "https://devicerts.com/categories/emdn/W05",
        "devices": 4
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 361,
    "all_devices_url": "https://devicerts.com/manufacturers/biosystems-sa",
    "items": [
      {
        "name": "alpha-AMYLASE - EPS",
        "url": "https://devicerts.com/devices/alpha-amylase-eps-11534",
        "model_reference": "11534",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-11538",
        "model_reference": "11538",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose-Hexokinase",
        "url": "https://devicerts.com/devices/glucose-hexokinase-12756",
        "model_reference": "12756",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - EPS",
        "url": "https://devicerts.com/devices/alpha-amylase-eps-21534",
        "model_reference": "21534",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Calibrator",
        "url": "https://devicerts.com/devices/biochemistry-calibrator-18011",
        "model_reference": "18011",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - DIRECT",
        "url": "https://devicerts.com/devices/alpha-amylase-direct-23550",
        "model_reference": "23550",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Creatine Kinase-Mb (Ck-Mb)",
        "url": "https://devicerts.com/devices/creatine-kinase-mb-ck-mb-23792",
        "model_reference": "23792",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - DIRECT",
        "url": "https://devicerts.com/devices/alpha-amylase-direct-11550",
        "model_reference": "11550",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-11504",
        "model_reference": "11504",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE-PANCREATIC",
        "url": "https://devicerts.com/devices/alpha-amylase-pancreatic-12799",
        "model_reference": "12799",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - DIRECT",
        "url": "https://devicerts.com/devices/alpha-amylase-direct-11583",
        "model_reference": "11583",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - DIRECT",
        "url": "https://devicerts.com/devices/alpha-amylase-direct-21550",
        "model_reference": "21550",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Creatine Kinase-Mb (Ck-Mb)",
        "url": "https://devicerts.com/devices/creatine-kinase-mb-ck-mb-11792",
        "model_reference": "11792",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose-Hexokinase",
        "url": "https://devicerts.com/devices/glucose-hexokinase-21656",
        "model_reference": "21656",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-12503",
        "model_reference": "12503",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-11803",
        "model_reference": "11803",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Creatine Kinase-Mb (Ck-Mb)",
        "url": "https://devicerts.com/devices/creatine-kinase-mb-ck-mb-12566",
        "model_reference": "12566",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-21503",
        "model_reference": "21503",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Creatine Kinase-Mb (Ck-Mb) Standard",
        "url": "https://devicerts.com/devices/creatine-kinase-mb-ck-mb-standard-11824",
        "model_reference": "11824",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - EPS",
        "url": "https://devicerts.com/devices/alpha-amylase-eps-12535",
        "model_reference": "12535",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Urine I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-urine-i-ii-18054",
        "model_reference": "18054",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-18009",
        "model_reference": "18009",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Calibrator (Human)",
        "url": "https://devicerts.com/devices/biochemistry-calibrator-human-18044",
        "model_reference": "18044",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Urine I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-urine-i-ii-18066",
        "model_reference": "18066",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE-PANCREATIC",
        "url": "https://devicerts.com/devices/alpha-amylase-pancreatic-11799",
        "model_reference": "11799",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose-Hexokinase",
        "url": "https://devicerts.com/devices/glucose-hexokinase-11656",
        "model_reference": "11656",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-18005",
        "model_reference": "18005",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-23503",
        "model_reference": "23503",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE - DIRECT",
        "url": "https://devicerts.com/devices/alpha-amylase-direct-12550",
        "model_reference": "12550",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-18010",
        "model_reference": "18010",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii (Human)",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-human-18042",
        "model_reference": "18042",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose-Hexokinase",
        "url": "https://devicerts.com/devices/glucose-hexokinase-23656",
        "model_reference": "23656",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Creatine Kinase-Mb (Ck-Mb)",
        "url": "https://devicerts.com/devices/creatine-kinase-mb-ck-mb-21792",
        "model_reference": "21792",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Glucose",
        "url": "https://devicerts.com/devices/glucose-11503",
        "model_reference": "11503",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-18007",
        "model_reference": "18007",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "alpha-AMYLASE-PANCREATIC",
        "url": "https://devicerts.com/devices/alpha-amylase-pancreatic-21799",
        "model_reference": "21799",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Biochemistry Control Serum I/Ii (Human)",
        "url": "https://devicerts.com/devices/biochemistry-control-serum-i-ii-human-18043",
        "model_reference": "18043",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ck-Mb Control Serum I/Ii",
        "url": "https://devicerts.com/devices/ck-mb-control-serum-i-ii-18061",
        "model_reference": "18061",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ck-Mb Control Serum I/Ii",
        "url": "https://devicerts.com/devices/ck-mb-control-serum-i-ii-18024",
        "model_reference": "18024",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bilirubin (Direct)",
        "url": "https://devicerts.com/devices/bilirubin-direct-11511",
        "model_reference": "11511",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bilirubin (Total)",
        "url": "https://devicerts.com/devices/bilirubin-total-11544",
        "model_reference": "11544",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "beta2-MICROGLOBULIN CONTROLS",
        "url": "https://devicerts.com/devices/beta2-microglobulin-controls-31592",
        "model_reference": "31592",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)",
        "url": "https://devicerts.com/devices/anti-neutrophil-cytoplasmic-antbodies-anca-formalin-50055",
        "model_reference": "50055",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Copper-Paesa",
        "url": "https://devicerts.com/devices/copper-paesa-11837",
        "model_reference": "11837",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fitc/Evans (R)",
        "url": "https://devicerts.com/devices/fitc-evans-r-44836",
        "model_reference": "44836",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gbma Positive Control",
        "url": "https://devicerts.com/devices/gbma-positive-control-44678",
        "model_reference": "44678",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Alkaline Washing Solution",
        "url": "https://devicerts.com/devices/alkaline-washing-solution-ac17205",
        "model_reference": "AC17205",
        "device_class": "Class A",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ANTI-Jo1 ANTIBODIES",
        "url": "https://devicerts.com/devices/anti-jo1-antibodies-44864",
        "model_reference": "44864",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Fecal Occult Blood (Fob) Standard",
        "url": "https://devicerts.com/devices/fecal-occult-blood-fob-standard-31326",
        "model_reference": "31326",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Anti-Endomysium Antibodies (Aea)",
        "url": "https://devicerts.com/devices/anti-endomysium-antibodies-aea-44710",
        "model_reference": "44710",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "HX 1695779-1",
      "type": "Quality management system",
      "legislation": "IVDR",
      "notified_body": "TÜV Rheinland LGA Products GmbH",
      "issued": "2026-10-06",
      "expires": "2030-02-24",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}