# Meibomask

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/meibomask-meibomask-ps>
- Manufacturer: [Espansione Marketing SpA](https://devicerts.com/manufacturers/espansione-marketing-spa) (FDA registration: United States)
- Name in the registry: MEIBOMASK
- Device class: Class IIa (EU MDD / EU MDR)
- EMDN: Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
- EMDN: Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI 80563897MEIBOMASKD004E · registered 2026-06-23 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 80563897MEIBOMASKD004E · registered 2026-06-23 · status: Active

## Recalls

No recall on record.

## Identity

- Device name: Device for phototherapy in ophthalmology [EUDAMED]; "Devices with LED light technology (LLLT) for professional use in Ophthalmology" [EUDAMED]
- Model / reference: MEIBOMASK/PS [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08056389703003 [EUDAMED]; 08056389700484 [EUDAMED]
- Basic UDI-DI: 80563897MEIBOMASKD004E [EUDAMED]; B-08056389700484 [EUDAMED]
- EMDN code: Z12120299 [EUDAMED]; Z12120199 [EUDAMED]

## Classification

- Device class: Class IIa [EUDAMED]
- EU registration type: Standard device [EUDAMED]; Legacy device (under a directive) [EUDAMED]
- EU market of registration: Greece [EUDAMED]; Italy [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: Meibomask, Espansione Marketing SpA. deviCERTS medical device catalogue. https://devicerts.com/devices/meibomask-meibomask-ps (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/meibomask-meibomask-ps.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/meibomask-meibomask-ps
- 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.