EU → US Device Access

Baxter Medical Systems GmbH + Co. KG

DE-MF-000005071 · Germany · Saalfeld

Baxter Medical Systems GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 406 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa404
Class IIb2

Among these devices, 122 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 entryBaxter Medical Systems GmbH + Co. KG (DE) · FDA 3007143268
Devices in EUDAMED406
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
HZ 1786593-1issued2029-03-23

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