EU → US Device Access

Micromed srl

IT-MF-000009198 · Italy · Roma

Micromed srl is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb60
Class IIa8

Most frequent device types declared: PDMS, PFCL.

Among these devices, 68 are declared sterile, 60 implantable.

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 entryMICROMEDICS, INC. (US) · FDA 2183425
Devices in EUDAMED68
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
CVD000623issued2028-03-07
CVD000323issued2028-03-07
CSQ0007230223supplemented2028-03-07

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