EU → North America Device Access

MAM Baby AG

CH-MF-000008524 · Switzerland · Wollerau

MAM Baby AG is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa12

Authorised representative in the Union: MAM Health & Innovation GmbH.

Devices declared under this manufacturer

Catalogue references include 09001616717963, 116777, 70717900, 791800, 9001616717987, S355.

European nomenclature codes declared: V0299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMAM Baby AG (CH) · FDA 3016245319
Devices in EUDAMED12
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN12
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: United States only. MAM Baby AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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