EU → US Device Access

3DHISTECH Kft.

HU-MF-000014337 · Hungary · Budapest

3DHISTECH Kft. is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other22

Most frequent device types declared: PANNORAMIC 480 DX Digital Scanner, PANNORAMIC 250 Flash III DX Digital Scanner, PANNORAMIC 150 DX Digital Scanner, PANNORAMIC 75 DX Digital Scanner.

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 EUDAMED22
Country of registrationHungary
⚠️ 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.

Other manufacturers in Hungary

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