EU → North America Device Access

Capsulit spa

IT-MF-000013452 · Italy · Roncello MB

Capsulit spa is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa66

Most frequent device types declared: Bicchierini e cucchiaini dosatori.

Among these devices, 66 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 66 declared devices.

Catalogue references include P32010H000, P3403060C6, P3403060D8, P3412060E4, P341802000, P342002000.

European nomenclature codes declared: V0499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED66
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 GTIN66
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. Capsulit spa was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
55391issued2027-08-08

Other manufacturers in Italy

All Italy manufacturers →