EU → North America Device Access

Schaerer Medical AG

CH-MF-000038078 · Switzerland · Münsingen

Schaerer Medical AG is registered in the European database on medical devices as a manufacturer, with 98 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa98

Among these devices, 2 are declared active.

Authorised representative in the Union: Intelleg Management GmbH.

Devices declared under this manufacturer

Showing 12 of 98 declared devices.

Catalogue references include 90334, 90351, 90609, 90662, 90759, 90988.

European nomenclature codes declared: Z12011202, Z12130202, Z12011280, P0999, Z11030503, Z12011299.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySCHAERER MEDICAL AG (CH) · FDA 3003900596
Devices in EUDAMED98
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN98
Found in the U.S. device database14
Share14.3 %

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. Schaerer Medical AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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