# MolecuLight i:X > Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [MolecuLight Inc.](https://devicerts.com/manufacturers/moleculight-inc) (Canada) - Device class: Class IIa (EU MDR) - EMDN: Z12019003 WOUND TREATMENT EQUIPMENT ## Overview *AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.* 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. The 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. ## Registrations and authorizations - **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 628110259TD0042C · UDI-DI 00628110259004 · registered 2026-05-01 · status: Active - **510(k)** · FDA 510(k) · United States · K213840 · issued 2022-05-18 · status: Active - **510(k)** · FDA 510(k) · United States · K210882 · issued 2021-06-22 · status: Active - **510(k)** · FDA 510(k) · United States · K191371 · issued 2019-12-04 · status: Active - **De Novo** · FDA De Novo · United States · DEN180008 · issued 2018-07-31 · status: Active ## Recalls No recall on record. ## Identity - Model / reference: MolecuLight i:X [EUDAMED]; 1105 [EUDAMED] ## Identifiers - Primary DI / UDI-DI: 00628110259004 [EUDAMED] - Basic UDI-DI: 628110259TD0042C [EUDAMED] - EMDN code: Z12019003 [EUDAMED] ## Classification - Device class: Class IIa [EUDAMED] - System or procedure pack: System which is a device in itself [EUDAMED] - EU registration type: Standard device [EUDAMED] - EU market of registration: Germany [EUDAMED] ## Properties - Supplied sterile: No [EUDAMED] - Sterilise before use: No [EUDAMED] - Implantable: No [EUDAMED] - Reusable: No [EUDAMED] - Contains latex: No [EUDAMED] - Reprocessed single-use device: No [EUDAMED] - Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED] - Incorporates a substance derived from human blood or plasma: No [EUDAMED] - Contains human tissues or cells: No [EUDAMED] - Contains animal tissues or cells: No [EUDAMED] - Contains endocrine-disrupting substances: No [EUDAMED] - Administering medicine: No [EUDAMED] - Measuring function: No [EUDAMED] - Incorporates a medicinal substance: No [EUDAMED] ## Source and citation - 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). - Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/) - Registry records last synced: 2026-10-24 - Statuses computed as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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 - 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.