EU → US Device Access

B. Braun Melsungen AG

DE-MF-000000201 · Germany · Melsungen

B. Braun Melsungen AG is registered in the European database on medical devices as a manufacturer, with 966 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa965
Class IIb1

Among these devices, 910 are declared sterile, 63 active, 157 with a measuring function.

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 MELSUNGEN AG (DE) · FDA 9610825
Devices in EUDAMED966
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G15 012974 0679supplemented2030-12-16
G12 012974 0651supplemented2028-10-11
G12 012974 0638supplemented2028-04-05
G11 012974 0626supplemented2026-12-14
G10 012974 0611supplemented2030-03-12

Other manufacturers in Germany

All Germany manufacturers →