EU → US Device Access

Newmed srl

IT-MF-000010414 · Italy · Quattro Castella

Newmed srl is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb59

Most frequent device types declared: Steam sterilizing units for medical purpose.

Among these devices, 59 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 EUDAMED59
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
042/MDRsupplemented2027-07-21

Other manufacturers in Italy

All Italy manufacturers →