EU → North America 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: mylife Distribution GmbH.

Devices declared under this manufacturer

Showing 12 of 45 declared devices.

Catalogue references include 700013494, MYOYP1851, MYOYP2-2481, MYOYP2481, MYOYP2491, MYOYP3181.

European nomenclature codes declared: Z120402160101, A03040101, A080201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED45
Country of registrationSwitzerland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN45
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. mylife Diabetes Care AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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