EU → North America Device Access

Piomic Medical AG

CH-MF-000013391 · Switzerland · Zürich

Piomic Medical AG is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Among these devices, 2 are declared sterile, 1 active.

Authorised representative in the Union: EUMEDIQ GmbH.

Devices declared under this manufacturer

Catalogue references include 01.0001, 01.0002, 01.0004, 01.0008.

European nomenclature codes declared: Z12019003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Piomic Medical AG was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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