EU → North America Device Access

ESPANSIONE MARKETING SPA

IT-MF-000027514 · Italy · FUNO DI ARGELATO

ESPANSIONE MARKETING SPA is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa21

Among these devices, 21 are declared active.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include EYE LAMP/CE-0500, EYE MASK/CE-ARR100, EYE MASK/CE-HB0250, EYE MASK/CE-HR2000, EYE MASK/CE-HY0500, ME-CHECK.

European nomenclature codes declared: Z12120299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryESPANSIONE MARKETING SPA (IT) · FDA 3010724743
Devices in EUDAMED21
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN21
Found in the U.S. device database1
Share4.8 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryESPANSIONE MARKETING S.P.A.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices1
Class 3 devices2
First licensed2020-01-20

Licence types: System (2), Single Device (1).

Licensed under: ME-CHECK, EYE-LIGHT, MEIBOMASK.

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