EU → US Device Access

Medicap S.r.l

IT-MF-000007995 · Italy · Carpi

Medicap S.r.l is registered in the European database on medical devices as a manufacturer, with 259 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb254
Class IIa5

Among these devices, 256 are declared sterile, 254 implantable, 2 reusable, 2 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 registerSimilar name found — unverified
Matched entryMEDICAPS CO., LTD. (KR) · FDA 3026391023
Devices in EUDAMED259
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
CVD000122issued2027-12-22
CSQ0002220223supplemented2027-12-22

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