EU → North America Device Access

LEVO AG

CH-MF-000008751 · Switzerland · Wohlen

LEVO AG is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Among these devices, 6 are declared active.

Authorised representative in the Union: be-on-market GmbH.

Catalogue references include JR/XS/35/40, KID/XS/35/33, LAE/S-M/48/57, LCEV/L-XL/42/51, LCM2, LEVO C3/48.

European nomenclature codes declared: Y122199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLEVO AG (CH) · FDA 9681680
Devices in EUDAMED8
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database1
Share12.5 %

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: United States only. LEVO AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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