{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "CareDx AB. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/caredx-ab (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/caredx-ab",
    "json_url": "https://devicerts.com/manufacturers/caredx-ab.json",
    "markdown_url": "https://devicerts.com/manufacturers/caredx-ab.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": "2026-11-14",
    "status_as_of": "2026-11-14",
    "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/caredx-ab",
    "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": "CareDx AB",
    "url": "https://devicerts.com/manufacturers/caredx-ab",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "Sweden",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "SE-MF-000040995"
      },
      {
        "label": "FDA FEI",
        "value": "3002522915"
      },
      {
        "label": "DUNS",
        "value": "558836388"
      }
    ],
    "summary": "CareDx AB is a medical device manufacturer based in Sweden, with 185 devices listed in EUDAMED and FDA GUDID (EU IVD Annex II List B, IVD General, Class C and Class A) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 185,
    "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": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 185
      },
      {
        "registry": "FDA GUDID",
        "devices": 165
      }
    ],
    "device_classes": [
      {
        "class": "EU IVD Annex II List B",
        "devices": 128
      },
      {
        "class": "EU IVD General",
        "devices": 44
      },
      {
        "class": "EU Class C",
        "devices": 12
      },
      {
        "class": "EU Class A",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "W01",
        "name": "Reagents",
        "url": "https://devicerts.com/categories/emdn/W01",
        "devices": 184
      },
      {
        "code": "V92",
        "name": "Medical device software - not included in other classes",
        "url": "https://devicerts.com/categories/emdn/V92",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 185,
    "all_devices_url": "https://devicerts.com/manufacturers/caredx-ab",
    "items": [
      {
        "name": "AlloSeq Tx",
        "url": "https://devicerts.com/devices/alloseq-tx-404-111-96",
        "model_reference": "404.111-96",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Olerup QTYPE LC480 II Cal Plate",
        "url": "https://devicerts.com/devices/olerup-qtype-lc480-ii-cal-plate-203-501-01",
        "model_reference": "203.501-01",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AlloSeq cfDNA",
        "url": "https://devicerts.com/devices/alloseq-cfdna-505-101-24",
        "model_reference": "505.101-24",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AlloSeq HCT",
        "url": "https://devicerts.com/devices/alloseq-hct-606-101-96",
        "model_reference": "606.101-96",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HLA Wipe Test",
        "url": "https://devicerts.com/devices/hla-wipe-test-102-101-01u",
        "model_reference": "102.101-01u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "QTYPE Colour Compensation Plate",
        "url": "https://devicerts.com/devices/qtype-colour-compensation-plate-203-501-01",
        "model_reference": "203.501-01",
        "device_class": "Class A",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AlloSeq Tx",
        "url": "https://devicerts.com/devices/alloseq-tx-404-112-96",
        "model_reference": "404.112-96",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*50",
        "url": "https://devicerts.com/devices/ssp-hla-b-50-101-548-06u",
        "model_reference": "101-548-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB1*09",
        "url": "https://devicerts.com/devices/ssp-drb1-09-101-120-06u",
        "model_reference": "101.120-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*03",
        "url": "https://devicerts.com/devices/ssp-hla-a-03-101-413-04u",
        "model_reference": "101.413-04u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB5*01:08N",
        "url": "https://devicerts.com/devices/ssp-drb5-01-08n-101-812-12u",
        "model_reference": "101.812-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*82",
        "url": "https://devicerts.com/devices/ssp-hla-b-82-101-552-06u",
        "model_reference": "101.552-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB4",
        "url": "https://devicerts.com/devices/ssp-drb4-101-122-06u",
        "model_reference": "101.122-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DPB1",
        "url": "https://devicerts.com/devices/ssp-dpb1-101-311-24u",
        "model_reference": "101.311-24u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-C*17",
        "url": "https://devicerts.com/devices/ssp-hla-c-17-101-628-06u",
        "model_reference": "101.628-06u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*44",
        "url": "https://devicerts.com/devices/ssp-hla-b-44-101-563-24u",
        "model_reference": "101.563-24u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*57",
        "url": "https://devicerts.com/devices/ssp-hla-b-57-101-567-12u",
        "model_reference": "101.567-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*5701",
        "url": "https://devicerts.com/devices/ssp-hla-b-5701-101-572-12u",
        "model_reference": "101.572-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*02",
        "url": "https://devicerts.com/devices/ssp-hla-a-02-101-412-24u",
        "model_reference": "101.412-24u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*68",
        "url": "https://devicerts.com/devices/ssp-hla-a-68-101-418-04u",
        "model_reference": "101.418-04u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*49",
        "url": "https://devicerts.com/devices/ssp-hla-b-49-101-547-06u",
        "model_reference": "101.547-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "AlloSeq Tx",
        "url": "https://devicerts.com/devices/alloseq-tx-404-172-96",
        "model_reference": "404.172-96",
        "device_class": "Class C",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*18",
        "url": "https://devicerts.com/devices/ssp-hla-b-18-101-519-12u",
        "model_reference": "101.519-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SSP HLA-B*27 high",
        "url": "https://devicerts.com/devices/ssp-hla-b-27-high-101-521-24u",
        "model_reference": "101.521-24u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*13",
        "url": "https://devicerts.com/devices/ssp-hla-b-13-101-515-12u",
        "model_reference": "101.515-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DQB1*05",
        "url": "https://devicerts.com/devices/ssp-dqb1-05-101-211-24u",
        "model_reference": "101.211-24u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DQB1*06",
        "url": "https://devicerts.com/devices/ssp-dqb1-06-101-212-24u",
        "model_reference": "101.212-24u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*07",
        "url": "https://devicerts.com/devices/ssp-hla-b-07-101-512-03u",
        "model_reference": "101.512-03u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-C*14",
        "url": "https://devicerts.com/devices/ssp-hla-c-14-101-625-06u",
        "model_reference": "101.625-06u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Olerup QTYPE 11",
        "url": "https://devicerts.com/devices/olerup-qtype-11-201-701-03",
        "model_reference": "201.701-03",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB1*14",
        "url": "https://devicerts.com/devices/ssp-drb1-14-101-117-12u",
        "model_reference": "101.117-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DQB1*03",
        "url": "https://devicerts.com/devices/ssp-dqb1-03-101-124-06u",
        "model_reference": "101.124-06u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*24",
        "url": "https://devicerts.com/devices/ssp-hla-a-24-101-422-24u",
        "model_reference": "101.422-24U",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB1*07",
        "url": "https://devicerts.com/devices/ssp-drb1-07-101-118-24u",
        "model_reference": "101.118-24u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*37",
        "url": "https://devicerts.com/devices/ssp-hla-b-37-101-541-06u",
        "model_reference": "101.541-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*14",
        "url": "https://devicerts.com/devices/ssp-hla-b-14-101-524-12u",
        "model_reference": "101.524-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SSP DQB1 high",
        "url": "https://devicerts.com/devices/ssp-dqb1-high-101-221-12u",
        "model_reference": "101.221-12u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SSP HLA C high",
        "url": "https://devicerts.com/devices/ssp-hla-c-high-101-707-12u",
        "model_reference": "101.707-12u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-C*04",
        "url": "https://devicerts.com/devices/ssp-hla-c-04-101-612-12u",
        "model_reference": "101.612-12u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DPA1",
        "url": "https://devicerts.com/devices/ssp-dpa1-101-331-24u",
        "model_reference": "101.331-24u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp DRB5",
        "url": "https://devicerts.com/devices/ssp-drb5-101-123-24u",
        "model_reference": "101.123-24u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*44",
        "url": "https://devicerts.com/devices/ssp-hla-b-44-101-563-03u",
        "model_reference": "101.563-03u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*68",
        "url": "https://devicerts.com/devices/ssp-hla-a-68-101-418-12u",
        "model_reference": "101.418-12u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-A*69",
        "url": "https://devicerts.com/devices/ssp-hla-a-69-101-435-06u",
        "model_reference": "101.435-06u",
        "device_class": "IVD Annex II List B",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SSP KIR Genotyping",
        "url": "https://devicerts.com/devices/ssp-kir-genotyping-104-101-12u",
        "model_reference": "104.101-12u",
        "device_class": "IVD General",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Ssp Hla-B*40",
        "url": "https://devicerts.com/devices/ssp-hla-b-40-101-523-03u",
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        "device_class": "IVD Annex II List B",
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          "GUDID"
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        "status": "Active",
        "decision_date": null,
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      {
        "name": "Ssp Hla-C*07",
        "url": "https://devicerts.com/devices/ssp-hla-c-07-101-615-24u",
        "model_reference": "101.615-24u",
        "device_class": "IVD General",
        "registries": [
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        "status": "Active",
        "decision_date": null,
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      {
        "name": "Ssp DQB1*03",
        "url": "https://devicerts.com/devices/ssp-dqb1-03-101-214-24u",
        "model_reference": "101.214-24u",
        "device_class": "IVD General",
        "registries": [
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        "status": "Active",
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      },
      {
        "name": "Ssp Hla-C*15",
        "url": "https://devicerts.com/devices/ssp-hla-c-15-101-626-12u",
        "model_reference": "101.626-12u",
        "device_class": "IVD General",
        "registries": [
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        "status": "Active",
        "decision_date": null,
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      },
      {
        "name": "Ssp Hla-B*39",
        "url": "https://devicerts.com/devices/ssp-hla-b-39-101-566-04u",
        "model_reference": "101.566-04u",
        "device_class": "IVD Annex II List B",
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    ]
  },
  "certificates": [
    {
      "number": "HX 7091956-1",
      "type": "Quality management system",
      "legislation": "IVDR",
      "notified_body": "TÜV Rheinland LGA Products GmbH",
      "issued": "2026-09-18",
      "expires": "2030-09-23",
      "status": "supplemented",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}