EU → US Device Access

Eufoton Srl

IT-MF-000009227 · Italy · Trieste

Eufoton Srl is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa54
Class IIb21

Most frequent device types declared: Eufoton Optical Fibers Type C, LASEmaR, LASEmaR Mini, EFLM-ME-04B-RD-S, EFLM-ME-06B-RD-S.

Among these devices, 59 are declared sterile, 15 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 EUDAMED75
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
ITH 1024592 1supplemented2029-05-15
ITD 1024592 1issued2029-05-15

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