EU → US Device Access

Helmedica AG

CH-MF-000040546 · Switzerland · Winterthur

Helmedica AG is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Patienten-App.

Among these devices, 5 are declared active.

Authorised representative in the Union: DE-AR-000005590.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationSwitzerland
⚠️ 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.

Other manufacturers in Switzerland

All Switzerland manufacturers →