EU → US Device Access

Polident d.o.o. Industrija dentalnih proizvodov

SI-MF-000000740 · Slovenia · Volcja Draga

Polident d.o.o. Industrija dentalnih proizvodov is registered in the European database on medical devices as a manufacturer, with 4 376 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4 376

Most frequent device types declared: Type 1/Type 2.

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 EUDAMED4 376
Country of registrationSlovenia
⚠️ 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
MDR-0014restricted2029-07-29

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