EU → US Device Access

Pressalit A/S

DK-MF-000001767 · Denmark · Ry

Pressalit A/S is registered in the European database on medical devices as a manufacturer, with 603 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa603

Most frequent device types declared: RT1, R85, R37, R74, R48.

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 registerSimilar name found — unverified
Matched entryPRESSALIT (DK) · FDA 3003947878
Devices in EUDAMED603
Country of registrationDenmark
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Denmark

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