{ "format": "devicerts.device.v1", "cite_as": "ROTEM® star-tem® 20, Tem Innovations GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/rotem-r-503-10-us (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/rotem-r-503-10-us", "json_url": "https://devicerts.com/devices/rotem-r-503-10-us.json", "markdown_url": "https://devicerts.com/devices/rotem-r-503-10-us.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": "2026-10-25", "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/devices/rotem-r-503-10-us", "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": "ROTEM® star-tem® 20", "registry_name": "ROTEM® star-tem® 20", "url": "https://devicerts.com/devices/rotem-r-503-10-us", "manufacturer": { "name": "Tem Innovations GmbH", "url": "https://devicerts.com/manufacturers/tem-innovations-gmbh", "country": null, "country_basis": null, "fda_registration_country": "Germany" }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "IVD General", "system": "EU IVDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "503-10-US", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "04260160470099", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-04260160470099", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K083842", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GGN", "JPA" ], "emdn": [ { "code": "W0103020899", "term": "HAEMOSTASIS RT & POC - OTHER" } ], "gmdn": [ { "code": "30595", "term": "Multiple coagulation marker IVD, reagent" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/IVDD", "number": "B-04260160470099", "number_label": "Basic UDI-DI", "device_udi_di": "04260160470099", "date": "2026-08-06", "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": "04260160470099", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-09-16", "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": "K083842", "number_label": null, "device_udi_di": null, "date": "2010-03-23", "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-1090-2016", "classification": "Class II", "status": "terminated", "initiated": "2016-02-18", "reason": "Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.", "applies": "this device", "via": "K083842" }, { "number": "Z-1379-2015", "classification": "Class II", "status": "terminated", "initiated": "2014-10-23", "reason": "Some of vials were found to be partially filled.", "applies": "this device", "via": "K083842" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "star-tem", "registries": [ "EUDAMED" ] }, { "value": "ROTEM®", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Multiple coagulation marker IVD, reagent", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "503-10", "registries": [ "EUDAMED" ] }, { "value": "star-tem® 20", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "503-10-US", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "04260160470099", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-04260160470099", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K083842", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "GGN", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "JPA", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "W0103020899", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Multiple coagulation marker IVD, reagent", "code": "30595", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IVD General", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "864.5425", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Austria", "registries": [ "EUDAMED" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Reagent", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Near-patient testing", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Professional testing", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", 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"IVD kit", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Self-testing", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Companion diagnostics", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "IVD instrument", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Prescription use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }