EU → US Device Access

Tesi Elettronica e Sistemi Informativi S.p.A.

IT-MF-000021278 · Italy · Milano

Tesi Elettronica e Sistemi Informativi S.p.A. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7
other5
Class IIb1

Most frequent device types declared: DERMOX, EMOWEB, OPTINET, SYLOGY, BEDSIDECHECK.

Among these devices, 8 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 EUDAMED13
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
IT339901issued2030-02-06

Other manufacturers in Italy

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