EU → US Device Access

B. Braun Avitum AG

DE-MF-000005127 · Germany · Melsungen

B. Braun Avitum AG is registered in the European database on medical devices as a manufacturer, with 268 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb211
Class IIa57

Among these devices, 61 are declared sterile, 152 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 entryB. Braun Avitum AG (DE) · FDA 3004176176
Devices in EUDAMED268
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G15 066097 0125issued2030-10-01

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