EU → US Device Access

NORMA Instruments Zártkörűen Működő Részvénytársaság

HU-MF-000014244 · Hungary · Budapest

NORMA Instruments Zártkörűen Működő Részvénytársaság is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other61

Most frequent device types declared: NormaCont3+ KIT K1, Norma-iHClean, Norma-iRP51 OP, Norma-iRP51 , Norma-iRP31.

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 EUDAMED61
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.

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