EU → US Device Access

IVFtech ApS

DK-MF-000025666 · Denmark · Birkerød

IVFtech ApS is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: 120, 150, 180, 210, 240, CO2, CO2/N2, 90, 120, 150, 180, 90, 120, 150, 180 210, 240, 90, 120.

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 EUDAMED8
Country of registrationDenmark
⚠️ 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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