EU → US Device Access

APIRO Diagnostics Kft.

HU-MF-000043501 · Hungary · Budaörs

APIRO Diagnostics Kft. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other10

Most frequent device types declared: 2021EU, 1041EU, 1031EU, 1061EU, 1051EU.

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 EUDAMED10
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

All Hungary manufacturers →