EU → US Device Access

RoweMed AG - Medical 4 Life

DE-MF-000005350 · Germany · Parchim

RoweMed AG - Medical 4 Life is registered in the European database on medical devices as a manufacturer, with 130 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa130

Among these devices, 130 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 entryRoweMed AG - Medical 4 Life (DE) · FDA 3007751444
Devices in EUDAMED130
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
2026GB448250304supplemented2028-02-02

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