{ "format": "devicerts.device.v1", "cite_as": "MolecuLight i:X, MolecuLight Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/moleculight-i-x-1105 (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/moleculight-i-x-1105", "json_url": "https://devicerts.com/devices/moleculight-i-x-1105.json", "markdown_url": "https://devicerts.com/devices/moleculight-i-x-1105.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/" } ], "registry_records_last_synced": "2026-10-24", "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/moleculight-i-x-1105", "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": "MolecuLight i:X", "registry_name": "MolecuLight i:X", "url": "https://devicerts.com/devices/moleculight-i-x-1105", "manufacturer": { "name": "MolecuLight Inc.", "url": "https://devicerts.com/manufacturers/moleculight-inc", "country": "Canada", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIa", "system": "EU MDR" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00628110259004", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "628110259TD0042C", "registries": [ "EUDAMED" ] } ] } ], "product_codes": [], "emdn": [ { "code": "Z12019003", "term": "WOUND TREATMENT EQUIPMENT" } ], "gmdn": [], "description": { "text": "The MolecuLight i:X is a Class IIa medical device classified under nomenclature code Z12019003, designed as an imaging system for detecting bacterial biofilm and other microbial infections in real time. It employs fluorescence technology to identify and visualise microbial presence on tissues and surfaces, aiding in the diagnosis and management of infectious conditions.\n\nThe MolecuLight i:X is supplied as a non-sterile, non-reusable device and is intended for single-use applications. It is not implantable or intended for use with medicinal products, human tissues, or animal tissues. The device is authorised under FDA 510K and MDR regulations, with a Basic UDI of 628110259TD0042C. It operates in non-MRI environments and requires proper storage as per manufacturer guidelines to maintain functionality.", "ai_generated": true, "generated_on": "2026-09-18", "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record." }, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDR", "number": "628110259TD0042C", "number_label": "Basic UDI-DI", "device_udi_di": "00628110259004", "date": "2026-05-01", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K213840", "number_label": null, "device_udi_di": null, "date": "2022-05-18", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K210882", "number_label": null, "device_udi_di": null, "date": "2021-06-22", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K191371", "number_label": null, "device_udi_di": null, "date": "2019-12-04", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "De Novo", "region": "United States", "type": "FDA De Novo", "number": "DEN180008", "number_label": null, "device_udi_di": null, "date": "2018-07-31", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Model / reference", "values": [ { "value": "MolecuLight i:X", "registries": [ "EUDAMED" ] }, { "value": "1105", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00628110259004", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "628110259TD0042C", "registries": [ "EUDAMED" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12019003", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIa", "registries": [ "EUDAMED" ] } ] }, { "label": "System or procedure pack", "values": [ { "value": "System which is a device in itself", "registries": [ "EUDAMED" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Standard device", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Germany", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains endocrine-disrupting substances", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] } ] } ] }