EU → US Device Access

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság

HU-MF-000017747 · Hungary · Budapest

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb5
Class IIa4

Most frequent device types declared: CA-1 AED.

Among these devices, 9 are declared active, 7 with a measuring function.

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 EUDAMED9
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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