EU → North America Device Access

Moldica S.r.l.

IT-MF-000056636 · Italy · Crocetta del Montello

Moldica S.r.l. is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa15

Most frequent device types declared: ARTY, CODY, FIDUS, JOY02, POLLIX.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include MPSTUTDITO, PAURSUPERIOR, PMEDARGO0UDX00B, PMEDARGO0USX00B, PMEDARTY, PMEDFIDUSWH, PMEDHARM02.

European nomenclature codes declared: Y061203, Y06120601, V0812, Y0599, Y060603, V0880.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN15
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Moldica S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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