EU → US Device Access

Drägerwerk AG & Co. KGaA

DE-MF-000005329 · Germany · Lübeck

Drägerwerk AG & Co. KGaA is registered in the European database on medical devices as a manufacturer, with 1 247 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 051
Class IIb196

Most frequent device types declared: 2030126K19Z000, 208019XK19L020, 2080366K19Z020, 2080366K19Z000, 2080366K19Z010.

Among these devices, 2 are declared sterile, 279 active, 72 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 registerNot found in the FDA register
Devices in EUDAMED1 247
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
G10 010578 0039supplemented2030-03-17

Other manufacturers in Germany

All Germany manufacturers →