EU → North America Device Access

Winform Medical Engineering S.R.L.

IT-MF-000031384 · Italy · San Donà di Piave

Winform Medical Engineering S.R.L. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: Dispositivo medico in CREMA da utilizzare in combinazione con apparecc, Dispositivo medico in gel.

Devices declared under this manufacturer

Catalogue references include CANL5002, CARKJMD5AIR, CBRL5002, CDEM5002, CFJXMD5AIR, CLIFEMD1.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Winform Medical Engineering S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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