EU → US 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.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED66
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
55391issued2027-08-08

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