EU → US Device Access

Medartis AG

CH-MF-000022291 · Switzerland · Basel

Medartis AG is registered in the European database on medical devices as a manufacturer, with 6 915 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb3 719
Class IIa3 196

Among these devices, 1 999 are declared sterile, 3 719 implantable, 1 098 reusable.

Authorised representative in the Union: DE-AR-000005810.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDARTIS AG (CH) · FDA 3003236702
Devices in EUDAMED6 915
Country of registrationSwitzerland

Notified body certificates

CertificateStatusExpiry
HZ 1809678-1supplemented2026-12-29

Other manufacturers in Switzerland

All Switzerland manufacturers →