EU → US Device Access

Lentismed d.o.o.

HR-MF-000018298 · Croatia · Zagreb

Lentismed d.o.o. is registered in the European database on medical devices as a manufacturer, with 290 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa290

Among these devices, 90 are declared sterile.

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 EUDAMED290
Country of registrationCroatia
⚠️ 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
M.2022.MDR.1008issued2027-12-11

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