EU → North America Device Access

Khymeia S.r.l.

IT-MF-000035617 · Italy · Padova

Khymeia S.r.l. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: 5.3, V_2.1.0.

Among these devices, 21 are declared active.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include COMPACT VRRS ENGINE A.I. KLOUD, KHY-SW-MEDICOAMICOPORTAL, PHYSIO, PHYSIO EVO A.I. KLOUD VRRS ENGINE, PHYSIO VRRS ENGINE, TR EVO A.I. VRRS ENGINE.

European nomenclature codes declared: Z12069099, Z12069092, Z12069080.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN21
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. Khymeia S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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