EU → North America Device Access

Klintensiv SRL

RO-MF-000041211 · Romania · Bragadiru

Klintensiv SRL is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Devices declared under this manufacturer

Catalogue references include 05949088411245, 5949088411184, 5949088411191, 5949088411221, 5949088411238.

European nomenclature codes declared: Z11040185.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationRomania

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

Device-level evidence

Devices with a numeric GTIN5
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. Klintensiv SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

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