EU → North America Device Access

QuantièmePlus SA

CH-MF-000011186 · Switzerland · Gland

QuantièmePlus SA is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa35

Most frequent device types declared: ReamerPlus.

Among these devices, 4 are declared sterile, 31 reusable.

Authorised representative in the Union: LAPE Médical.

Catalogue references include RM08, RM09, RM12, RM15, RM24, RM34.

European nomenclature codes declared: L091102, P091301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED35
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 GTIN35
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. QuantièmePlus SA was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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