EU → North America Device Access

Sanimed International Impex S.A.

RO-MF-000035897 · Romania · Calugareni

Sanimed International Impex S.A. is registered in the European database on medical devices as a manufacturer, with 540 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 540 declared devices.

Catalogue references include 105325, 108125, 128401, 20789, 32061, 400115.

European nomenclature codes declared: W0104010101, W0104010306, W0104010206, W0104010405, W0104010804, W0104080208.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED540
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 GTIN540
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. Sanimed International Impex S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Romania

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