EU → US Device Access

TRANSCENDENCIAS COMERCIALES, S.L.

ES-MF-000006640 · Spain · ASTIGARRAGA

TRANSCENDENCIAS COMERCIALES, S.L. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Z-13, Z-16, Z-20, Z-05, Z-09.

Among these devices, 4 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 entryTranscendencias Comerciales S.L (ES) · FDA 3005346382
Devices in EUDAMED11
Country of registrationSpain

Notified body certificates

CertificateStatusExpiry
059/MDRamended2027-11-21

Other manufacturers in Spain

All Spain manufacturers →