EU → US Device Access

CA-MI S.R.L.

IT-MF-000020076 · Italy · Langhirano (PR)

CA-MI S.R.L. is registered in the European database on medical devices as a manufacturer, with 365 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa365

Most frequent device types declared: SURGICAL SUCTION EQUIPMENT, AEROSOL THERAPY EQUIPMENT, ACCESSORIES FOR SURGICAL SUCTION EQUIPMENT, KITS FOR AEROSOL THERAPY, COLLECTION CONTAINER FOR MEASUREMENT OF ASPIRATED FLUIDS.

Among these devices, 316 are declared active.

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 EUDAMED365
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.

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