MolecuLight i:X

by MolecuLight Inc.

Ref 1105Model MolecuLight i:X

Active European Union and United States

CE MDR 510(k) De Novo

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213840↗

+3 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number628110259TD0042C Basic UDI-DI 00628110259004UDI-DI	Date1 May 2026Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK213840	Date18 May 2022Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK210882	Date22 Jun 2021Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK191371	Date4 Dec 2019Issued	StatusActive
United States	FDA De Novo De Novo	NumberDEN180008	Date31 Jul 2018Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 628110259TD0042C — open Devices and search for it
FDA 510(k) database 510(k) number K213840
FDA 510(k) database 510(k) number K210882
FDA 510(k) database 510(k) number K191371
FDA De Novo database De Novo number DEN180008

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 628110259TD0042C registered 1 May 2026 Active
FDA 510(k) K213840 decided 18 May 2022 Active· +2 more in the status table
FDA De Novo DEN180008 decided 31 Jul 2018 Active

Timeline

5 dated events

31 Jul 2018 Granted FDA De Novo DEN180008
4 Dec 2019 Cleared FDA 510(k) K191371
22 Jun 2021 Cleared FDA 510(k) K210882
18 May 2022 Cleared FDA 510(k) K213840
1 May 2026 Registered EUDAMED 628110259TD0042C

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k), FDA De Novo Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / reference: MolecuLight i:X, 1105

Primary DI / UDI-DI: 00628110259004
Basic UDI-DI: 628110259TD0042C
EMDN code: Z12019003 Wound treatment equipment

Device class: Class IIa
System or procedure pack: System which is a device in itself
EU registration type: Standard device
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CA-MF-000036119
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

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Properties

Other properties (14, all answered No)