EU → US Device Access

CAPENERGY MEDICAL, S.L.

ES-MF-000000877 · Spain · SANT JOAN DESPI (BARCELONA)

CAPENERGY MEDICAL, S.L. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Most frequent device types declared: C100, C500, C400, C50, C200.

Among these devices, 7 are declared active.

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 registerRegistered with FDA
Matched entryCAPENERGY MEDICAL, S.L. (ES) · FDA 3016675013
Devices in EUDAMED7
Country of registrationSpain

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