MolecuLight i:X
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- MolecuLight i:X EUDAMED
- Device Name
- MolecuLight i:X EUDAMED
- Model / Reference
- MolecuLight i:X EUDAMED1105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628110259004 EUDAMED
- Basic UDI-DI
- 628110259TD0042C EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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.
Frequently asked questions
What is the MolecuLight i:X used for in clinical settings and how does it work?
The MolecuLight i:X is designed to detect bacterial biofilm and other microbial infections in real time using fluorescence technology. It visualizes microbial presence on tissues and surfaces, helping clinicians identify and manage infectious conditions more effectively during procedures. The device does not replace diagnostic tests but provides immediate visual feedback to aid decision-making.
Is the MolecuLight i:X sterile, and can it be reused?
The MolecuLight i:X is explicitly supplied as a non-sterile device and is intended for single-use only. It is not designed for reprocessing or reuse, as confirmed by the ‘STERILE: 0’ and ‘REUSABLE: 0’ specifications. This ensures patient safety and maintains device functionality for one use per disposable component.
What storage requirements does the MolecuLight i:X have to maintain its performance?
The MolecuLight i:X requires proper storage as outlined by the manufacturer to preserve its functionality. While specific conditions (e.g., temperature, humidity) aren’t detailed here, the device is non-sterile and non-reusable, so storage should protect it from contamination and physical damage. Always follow MolecuLight Inc.’s guidelines to ensure optimal performance and compliance with regulatory standards.
How do I identify the correct model or version of the MolecuLight i:X, and is there a unique identifier for it?
The MolecuLight i:X is the sole model listed, with a Basic UDI (Unique Device Identifier) of 628110259TD0042C for traceability. This UDI includes a ULID (01KQJ0PP2S9QHJ3YZNVG21ZGPR) and UUID (1072a877-7150-46a5-9e1a-e4c5656d3156) for regulatory and inventory purposes. The version number is 1, confirming it’s the latest iteration as of the data provided.
Can the MolecuLight i:X be used in an MRI environment, and what regulatory pathways does it follow?
The MolecuLight i:X is not intended for MRI environments, as explicitly noted in the device specifications. Regulatory-wise, it follows the FDA 510K pathway in the U.S. and the EU Medical Device Regulation (MDR) in Europe, with authorization handled by Emergo Europe B.V. (SRN: NL-AR-000000116). These pathways ensure compliance with safety and performance standards for Class IIa devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210882 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | DEN180008 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191371 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213840 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 628110259TD0042C | Class IIa | Active |
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Manufacturer
- Manufacturer
- MolecuLight Inc.
- EUDAMED SRN
- CA-MF-000036119
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d32bd644-b2aa-4727-9a5d-b7ea50201129 61 fields · synced Sep 18, 2026
- FDA 510(k) K210882 1 fields · synced May 18, 2026