EU → US Device Access

B. Braun Surgical, S.A.

ES-MF-000002083 · Spain · Rubí

B. Braun Surgical, S.A. is registered in the European database on medical devices as a manufacturer, with 89 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb89

Among these devices, 89 are declared sterile.

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 entryB. BRAUN SURGICAL, S.A. (ES) · FDA 3025308493
Devices in EUDAMED89
Country of registrationSpain

Notified body certificates

CertificateStatusExpiry
G11 025701 0102issued2027-07-18
G12 025701 0096supplemented2027-07-18
G10 025701 0095supplemented2027-07-18

Other manufacturers in Spain

All Spain manufacturers →