EU → US Device Access

mylife Diabetes Care AG

CH-MF-000044659 · Switzerland · Burgdorf

mylife Diabetes Care AG is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb44
Class IIa1

Among these devices, 22 are declared sterile, 23 active, 23 with a measuring function.

Authorised representative in the Union: DE-AR-000005922.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED45
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.

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