EU → US Device Access

pro3dure medical GmbH

DE-MF-000000024 · Germany · Iserlohn

pro3dure medical GmbH is registered in the European database on medical devices as a manufacturer, with 379 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa379

Most frequent device types declared: 12140201, 12090203, 12140101, 12140202, 12090204.

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 entryPRO3DURE MEDICAL GMBH (DE) · FDA 3014888923
Devices in EUDAMED379
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
44911221079issued2031-01-25

Other manufacturers in Germany

All Germany manufacturers →