EU → US Device Access

BSN medical GmbH

DE-MF-000005787 · Germany · Hamburg

BSN medical GmbH is registered in the European database on medical devices as a manufacturer, with 1 261 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 215
Class IIb46

Among these devices, 153 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 entryBSN Medical GmbH (DE) · FDA 3017297225
Devices in EUDAMED1 261
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
50708-60-06-01supplemented2030-12-14

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