{ "format": "devicerts.device.v1", "cite_as": "Behring Coagulation Cup 10446526, Siemens Healthcare Diagnostics Products Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/behring-coagulation-cup-ovis31 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/behring-coagulation-cup-ovis31", "json_url": "https://devicerts.com/devices/behring-coagulation-cup-ovis31.json", "markdown_url": "https://devicerts.com/devices/behring-coagulation-cup-ovis31.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-22", "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/devices/behring-coagulation-cup-ovis31", "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." }, "device": { "name": "Behring Coagulation Cup 10446526", "registry_name": "Behring Coagulation Cup 10446526", "url": "https://devicerts.com/devices/behring-coagulation-cup-ovis31", "manufacturer": { "name": "Siemens Healthcare Diagnostics Products Ltd", "url": "https://devicerts.com/manufacturers/siemens-healthcare-diagnostics-products-ltd", "country": null, "country_basis": null, "fda_registration_country": "Germany" }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class A", "system": "EU IVDR" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "OVIS31", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00842768012198", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "0405686902105UY", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K970431", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GKP", "JPA" ], "emdn": [ { "code": "W0202020185", "term": "COAGULOMETERS - CONSUMABLES" } ], "gmdn": [ { "code": "62225", "term": "Assay container IVD, single-use" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/IVDR", "number": "0405686902105UY", "number_label": "Basic UDI-DI", "device_udi_di": "00842768012198", "date": "2026-07-10", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00842768012198", "number_label": "UDI-DI", "device_udi_di": null, "date": "2017-10-31", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K970431", "number_label": null, "device_udi_di": null, "date": "1997-05-05", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-1435-2021", "classification": "Class II", "status": "terminated", "initiated": "2021-03-02", "reason": "Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.", "applies": "shared submission", "via": "K970431" }, { "number": "Z-0825-2016", "classification": "Class II", "status": "terminated", "initiated": "2016-01-14", "reason": "False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.", "applies": "shared submission", "via": "K970431" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Behring Coagulation Cup", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Assay container IVD, single-use", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "IVDR_27_MAR EB_A_Behring_Coag_Cup", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "10446526", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "IVDR_27_MAR EB_A_Behring_Coag_Cup", "registries": [ "EUDAMED" ] }, { "value": "OVIS31", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00842768012198", 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