EU → North America Device Access

ADALTIS SRL

IT-MF-000028990 · Italy · Milano

ADALTIS SRL is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: ++M52107106LG, ++M52108131C.

Devices declared under this manufacturer

Catalogue references include 071011 / 071012 / 071015, 081141 / 081142 / 081145, 081311C / 081312C / 081315C, ELB01, MDX01, ME188830.

European nomenclature codes declared: W02039006, W0201020103, W0105900101, W0105020201, W0105010302, W0105030404.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryADALTIS INC.

North American profile: Canada only. ADALTIS SRL holds a Canadian licence but was not found in the U.S. register.

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